NCT05102019ClinicalTrials.gov

Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

Interventistico380 partecipanti ricercati96 centri3 paesi

Categorie

Cardiovascolare94%Apparato muscoloscheletrico6%

Registrato in 1 registro

ClinicalTrials.govNCT05102019Apri questa scheda su ClinicalTrials.govSincronizzato 4 settimane fa

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

Ti interessa questo studio?

Accedi oppure crea un account per registrare il tuo interesse e seguire questo studio.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2021-11-01; recorded start 2022-01-04
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 6 other studies in this databaseCounted from the lead sponsor named in the record (Shockwave Medical, Inc.)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding13/20
Double-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 95 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 380 participants (target), run at 96 sites, across 3 countries.

How this score is built

Enrolment25/40
380 participants (target)
Site count22/25
95 sites
Country count7/15
3 countries
Planned duration10/10
Planned over about 122 months
Sponsor scale3/10
Shockwave Medical, Inc. has led 7 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Sintesi

To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.

The COSIRA-II study is a multicenter, randomized (1:1 ratio), double-blinded, sham-controlled clinical trial.

Patologie

Refractory Angina

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – Nessun massimo
Volontari sani	No

Idoneità come riportata nel registro

Inclusion Criteria: 1. Subject is older than 18 years of age 2. Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III or IV despite maximally tolerated guideline directed medical therapy as determined by the local heart team and confirmed by a Central Screening Eligibility Committee Note: subjects may also have exertional dyspnea, but the symptoms that limit activity must be anginal in nature (including chest pain, pressure, heaviness, discomfort, with or without radiation to the neck, jaw, shoulders, arms, or other location) and not dyspnea 3. Must have attempted treatment with the maximally tolerated dose of at least three of the four (preferably all four) approved classes of anti-anginal agents: long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for at least 30 days prior to enrollment, must remain stable from enrollment to randomization, and there must be no intent to change the medical regimen for at least 12 months after randomization Note: If the dose of a medication was increased or decreased for a temporary period and then returned to the original dose, which will then be continued for at least 12 months after randomization, the subject may be immediately enrolled without needing to otherwise requalify 4. Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, or is otherwise unsuitable or high risk for revascularization as determined by the local heart team, and confirmed by a Central Screening Eligibility Committee 5. Evidence of either exercise or pharmacologically induced reversible ischemia severity by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFR-CT, FFR, iFR, or other non-hyperemic FDA approved tests (such as diastolic hyperaemia free ratio \[DRF\] or resting full-cycle ratio \[RFR\] in the distribution of the left coronary artery (LCA), performed within 12 months prior to enrollment Note: If the subject has evidence of ischemia in both the LCA and RCA distributions, the extent of ischemia must be greater in the LCA distribution Note: The qualifying assessment must be performed after any myocardial infarction, CABG, or successful PCI within the prior 12 months. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study 6. Functional limitation due to refractory angina as defined by a modified Bruce exercise tolerance test duration of greater than or equal to 2 minutes but less than or equal to 10 minutes, performed while the subject is maintained on their stable regimen of maximally tolerated doses of anti-anginal medications Note: The ETT variability must be less than 20% between last two ETTs performed. 7. Left ventricular ejection fraction (LVEF) greater than or equal to 30% within the 12-months prior to enrollment Note: The LVEF must be reassessed after any intervening myocardial infarction. For subjects with multiple assessments, the most recent LVEF assessment is used as the qualifying test. 8. Subject is willing and able to sign informed consent 9. Subject is willing to comply with the specified follow-up evaluations Angiographic Inclusion Criteria: 1\) Three-vessel coronary angiography performed within 12 months prior to enrollment demonstrating obstructive CAD (visually estimated diameter stenosis of ≥70% or ≥50% - \<70% with fractional flow reserve (FFR) value of ≤0.80 or an iFR or other FDA-approved/cleared non-hyperemic physiological assessment (such as DFR or RFR) of ≤0.89 in one or more lesions) in the left coronary artery (main epicardial vessels or branches) that is not suitable for and will not be treated with PCI or CABG as determined by the local heart team Note: The qualifying 3-vessel angiogram must be performed after any myocardial infarction, PCI, or CABG within the 12 months prior to enrollment. For patients with multiple 3-vessel angiograms, the one performed closest to enrollment will serve as the qualifying study Exclusion Criteria: 1. Recent (within 30 days prior to enrollment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI) Note: subjects with an elevated troponin or CKMB without acute coronary syndrome may still be enrolled 2. Recent successful revascularization by either CABG or PCI within six months prior to enrollment Note: Successful revascularization is defined as any CABG procedure, or any PCI procedure with a reduction of one or more lesions to \<50% diameter stenosis Note: Subjects with successful revascularization by either CABG or PCI that occurred less than six months prior to enrollment may still be approved for participation in the trial if revascularization was completed six months prior to procedure and CSEC approves subject participation 3. Recent unsuccessful PCI (e.g., failed attempt to open a chronic total occlusion) within 30 days prior to enrollment Note: Subjects with unsuccessful PCI that occurred less than 30 days prior to enrollment may still be approved for participation in the trial if PCI was completed 30 days prior to procedure and CSEC approves subject participation 4. The predominant manifestation of angina is dyspnea Note: some dyspnea may be present with exertion, but the predominant symptom that limits activity must be angina (i.e., chest pain, pressure, tightness, heaviness, or discomfort, with or without radiation to the neck, jaw, shoulders, arms, or other location) 5. Has extra-coronary contributory causes of angina - e.g., untreated hyperthyroidism, untreated anemia (hgb \<10 g/dL), uncontrolled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg despite medications), atrial fibrillation with rapid ventricular response (consistently \>100 bpm despite medications) or other tachyarrhythmia, severe aortic stenosis, hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric left ventricular hypertrophy is not an exclusion criterion), or epicardial vasospasm disease/coronary artery vasospasm (CAS)/vasospastic angina (VSA) 6. NYHA Class III or IV heart failure (HF), decompensated HF or hospitalization due to HF during the 90 days prior to enrollment 7. Life threatening rhythm disorders or any rhythm disorders that would require future placement of an internal defibrillator and/or pacemaker 8. Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second (FEV1) that is less than 55% of the predicted value, or need for home daytime oxygen or oral steroids 9. Severe valvular heart disease (any valve) 10. Moderate or severe RV dysfunction by echocardiography 11. Pacemaker electrode/lead is present in the coronary sinus 12. A Class I indication is present for an implantable defibrillator or cardiac resynchronization therapy according to ACCF/AHA/HRS guidelines 13. Recent implantation of a new pacemaker or defibrillator lead with electrode in the right atrium within 90 days of enrollment 14. Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD formula) or subjects on chronic dialysis 15. Known allergy to stainless steel or nickel 16. Any clinical condition that might interfere with the trial protocol or the subject's ability to be compliant with the trial protocol (e.g., active alcohol or drug abuse, dementia, magnetic resonances imaging (MRI) planned within 8 weeks of procedure) 17. Currently enrolled in another investigational device or drug trial that has not reached its primary endpoint or that might clinically interfere with the current trial endpoints or procedures 18. Pregnant or planning pregnancy within the next 12 months (women of reproductive potential must have a negative pregnancy test within 7 days of the procedure) 19. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention. 20. Inability to tolerate dual antiplatelet therapy for 6 months if not on a chronic oral anticoagulant, or inability to tolerate a P2Y12 inhibitor for at least 6 months if on a chronic oral anticoagulant 21. Comorbidities limiting life expectancy to less than one year 22. Subject is currently hospitalized for definite or suspected COVID-19 23. Subject has previously been symptomatic with or hospitalized for COVID-19 and has been asymptomatic for \<8 weeks prior to enrollment or has not returned to his or her prior baseline (pre-COVID-19) clinical condition 24. Subject is asymptomatic but has had a positive PCR or antigen test for COVID-19 within the past 4 weeks prior to enrollment Angiographic/Hemodynamic Exclusion Criteria: 1\) Coronary anatomy amenable to revascularization of ischemic myocardial territory by either PCI or CABG with at least moderate likelihood of long-term alleviation of angina or angina equivalent symptoms, as per the assessment of the local heart team. Note: If a pathway to coronary revascularization is present which, in the opinion of the local heart team, is reasonably low risk and reasonably likely to provide long-term symptom relief and the subject refuses the revascularization procedure, the patient is ineligible for randomization Procedural Angiographic/Hemodynamic Randomization Exclusion Criteria: 1. Mean right atrial pressure greater than 15 mmHg assessed during the final screening procedure for eligibility assessment and potential randomization 2. Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava \[SVC\]) as demonstrated by angiogram 3. The CS diameter at the most proximal end of the planned implant region (2-4 cm distal to the coronary sinus ostium) is less than 9.5 mm or greater than 13.0 mm Single-arm Registry (Unblinded, Non-Randomized Treatment Arm) Inclusion/Exclusion Criteria: Subject can be included in the single-arm registry if they fall into one of the three categories with inclusions and exclusion criteria as described below. Predominant right coronary disease subjects (RCA): 1. Reversible ischemia: Subjects with evidence of either exercise or pharmacologically induced reversible ischemia by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFR-CT, FFR, iFR, or other non-hyperemic FDA approved or cleared tests (such as DFR or RFR) in the distribution of the right coronary artery (RCA), performed within 12 months prior to enrollment. Note: If the subject has evidence of ischemia in both the LCA and RCA distributions, the extent of ischemia must be greater in the RCA distribution Note: The qualifying assessment must be performed after any myocardial infarction, CABG, or successful PCI within the prior 12 months. If the anti-anginal medication regimen is permanently changed after the assessment of ischemia, the test must be repeated. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study 2. Obstructive CAD: Three-vessel coronary angiography performed within the 12 months prior to enrollment demonstrating obstructive CAD (visually assessed diameter stenosis of ≥70% or ≥50% - \<70% with fractional flow reserve (FFR) value of ≤0.80 or an iFR or other FDA-approved/cleared non-hyperemic physiological assessment (such as DFR or RFR) of ≤0.89 in one or more lesions) in the RCA (main epicardial vessels or branches) that is not suitable for and will not be treated with PCI or CABG as determined by the local heart team. Note: The qualifying assessment must be performed after any myocardial infarction, PCI or CABG within the prior 12 months. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study 3. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #5 and angiographic inclusion #1) and none of the exclusion criteria of the main randomized trial Non-obstructive coronary artery disease subjects (ANOCA) 1. Abnormal Coronary Flow Reserve (CFR): subjects must have either abnormal PET CFR (\< 2.0), abnormal perfusion CMR (cardiac MRI) CFR (\<1.85), or abnormal invasive CFR (\<2.5) in at least one main epicardial coronary artery performed within 12 months prior to enrollment Note: Subjects may or may not have evidence of either exercise or pharmacologically induced reversible ischemia by stress echo, nuclear study, PET, perfusion MRI, or CT perfusion 2. Non-obstructive CAD: subjects have non-obstructive coronary disease (estimated diameter stenosis in all coronary lesions is \<50% and (if performed) FFR ≥0.81 or a non-hyperemic test is ≥0.90) demonstrated on three-vessel coronary angiography performed within the 12 months prior to enrollment. If an estimated diameter stenosis is ≥50% to \<70%, the patient may still qualify if FFR ≥0.81 or a non-hyperemic test is ≥0.90 in that vessel. If both FFR and a non-hyperemic test are performed, both must be negative. Note: The qualifying 3-vessel angiogram must be performed after any myocardial infarction, PCI or CABG within the 12 months prior to enrollment. For patients with multiple 3-vessel angiograms, the one performed closest to enrollment will serve as the qualifying study 3. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #5 and angiographic inclusion #1) and none of the exclusion criteria of the main randomized trial Subjects unable to complete ETT 1. Subjects must be unable to complete the required COSIRA-II exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid (e.g., wheelchair, cane, rollator, crutches, or knee walker). 2. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #6) and none of the exclusion criteria of the main randomized trial Prior to inclusion in single-arm registry, all subjects will be reviewed by the Central Screening Eligibility Committee to ensure that they meet registry inclusion criteria and are not eligible for enrollment into the randomized study.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Non applicabile
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	TREATMENT
Mascheramento	DOUBLE (2)
Arruolamento	380 partecipanti ricercati

Sponsor e collaboratori

Shockwave Medical, Inc. Sponsor

Bracci e interventi

Arm 1 (treatment arm):Implantation of the Reducer deviceEXPERIMENTAL
Arm 2 (sham-control arm): Control (no device implantation)SHAM_COMPARATOR
Arm 3 (unblinded, non-randomized): Single Arm RegistryOTHER

Interventi

Dispositivo Arm 1: treatment with Shockwave Reducer
Shockwave reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
Altro Arm 2 (control): Implantation procedure with no device implanted
No device is implanted
Dispositivo Arm 3 (unblinded, non-randomized): Single arm registry
Shockwave Reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms

Esiti misurati

Esito primario
Co-Primary Effectiveness Endpoints
Change in total exercise duration in a modified Bruce treadmill exercise tolerance testing evaluation in the Treatment arm compared to Sham-control arm. Change in SAQ clinical summary score assessed at 6 months post procedure compared to baseline in the Treatment arm compared to the Sham-control arm.
Orizzonte temporale 6 months
Esito primario
Primary Safety Endpoints
The rate of occurrence of a composite of death, myocardial infarction (MI), pericardial effusion requiring surgical or percutaneous intervention, device embolization, or BARC 3 or 5 bleeding evaluation in the Treatment arm compared to the Sham-control arm.
Orizzonte temporale 6 months
Esito secondario
Canadian Cardiovascular Society (CCS) Angina Score
Improvement by greater than or equal to 1 CCS angina grade. The CCS grading system for angina is a clinical tool used by doctors to assess the degree of severity of a patient's angina. Possible scores range from Class 0 (asymptomatic angina) to Class IV (angina at rest).
Orizzonte temporale 6 months
Esito secondario
Canadian Cardiovascular Society (CCS) Angina Score
Improvement by greater than or equal to 2 CCS angina grades. The CCS grading system for angina is a clinical tool used by doctors to assess the degree of severity of a patient's angina. Possible scores range from Class 0 (asymptomatic angina) to Class IV (angina at rest).
Orizzonte temporale 6 months
Altro esito
Canadian Cardiovascular Society (CCS) Angina Score
Improvement by greater than or equal to 1 and greater than or equal to 2 CCS angina grades compared to baseline. The CCS grading system for angina is a clinical tool used by doctors to assess the degree of severity of a patient's angina. Possible scores range from Class 0 (asymptomatic angina) to Class IV (angina at rest).
Orizzonte temporale 12 months, 2 years, 3 years, 4 years, and 5 years
Altro esito
Angina Burden
Angina frequency and burden compared to baseline
Orizzonte temporale 6 and 12 months
Altro esito
Activity
Measure of activity assessed by actigraphy compared to baseline
Orizzonte temporale 6 and 12 months
Altro esito
Exercise Tolerance Testing
Change in ETT parameters compared to baseline
Orizzonte temporale 6 and 12 months
Altro esito
Exercise Tolerance Testing
Change in total exercise duration compared to baseline
Orizzonte temporale 12 months
Altro esito
Doctor Visits
Number of unplanned office visits due for angina, and any hospitalizations or emergency department visits (for angina, non-angina cardiovascular causes) post procedure compared to baseline
Orizzonte temporale 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Altro esito
Exercise Tolerance Testing
Total exercise duration
Orizzonte temporale 6 and 12 months
Altro esito
Seattle Angina Questionnaire (SAQ) Score
Change in other Seattle Angina Questionnaire (SAQ) domain scores and clinical summary score at 6 months (primary endpoint), 12 month and annually post procedure compared to baseline. The Seattle Angina Questionnaire (SAQ) is a disease-specific questionnaire used to quantify patients' symptoms of angina and the extent to which their angina affects their functioning and quality of life. Possible scores range from 0 (daily angina) to 100 (no angina). Lower scores indicate worse angina symptoms.
Orizzonte temporale 6 month, 12 month, 2 years, 3 years, 4 years, and 5 years
Altro esito
Adverse Events
Number of deaths, myocardial infarctions, strokes, unplanned revascularization procedures in-hospital, at 30 days, 3 months, 6 months, 12 months and annually post procedure
Orizzonte temporale 30 day, 6 month, 12 month, 2 years, 3 years, 4 years, and 5 years

Date

Date
Data di inizio	4 gennaio 2022 (effettiva)
Conclusione primaria	1 luglio 2027 (stimata)
Conclusione	1 gennaio 2032 (stimata)
Prima pubblicazione	1 novembre 2021 (effettiva)
Ultimo aggiornamento	26 agosto 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	agosto 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

91 centri stanno reclutando

Canada

Canada
Struttura	Città	Stato o regione	Stato
CHUM	Montreal	Quebec	In reclutamento
University of Ottawa Heart Institute	Ottawa	Ontario	In reclutamento
IUCPQ-Ulaval	Québec	Quebec	In reclutamento
Toronto General Hospital (UHN)	Toronto	Ontario	In reclutamento
Vancouver General Hospital	Vancouver	British Columbia	In reclutamento

United Kingdom

United Kingdom
Struttura	Città	Stato
Essex Cardiothoracic Centre	Basildon	In reclutamento
Queen Elizabeth Hospital Birmingham	Birmingham	In reclutamento
Bristol Heart Institute	Bristol	In reclutamento
Royal Papworth Hospital	Cambridge	In reclutamento
Dorset County Hospital NHS Foundation Trust	Dorchester	In reclutamento
Kettering General Hospital	Kettering	In reclutamento
Glenfield Hospital, Leicester	Leicester	In reclutamento
Liverpool Heart and Chest Hospital NHS Foundation Trust	Liverpool	In reclutamento
Royal Brompton Hospital	London	In reclutamento
Imperial College Healthcare NHS Trust	London	In reclutamento
St. Georges University Hospital	London	In reclutamento
King's College Hospital	London	In reclutamento
St. Thomas Hospital	London	In reclutamento
Royal Free Hospital	London	In reclutamento
Barts Health Centre	London	In reclutamento
Freeman Hospital	Newcastle upon Tyne	In reclutamento
Nottingham University Hospital	Nottingham	In reclutamento
Oxford University Hospital	Oxford	In reclutamento
Royal Bournemouth Hospital	Poole	In reclutamento
Musgrove Park Hospital	Taunton	In reclutamento

United States

United States
Struttura	Città	Stato o regione	Stato
University of Michigan	Ann Arbor	Michigan	In reclutamento
Emory Hospital	Atlanta	Georgia	In reclutamento
Northside Hospital	Atlanta	Georgia	Ritirato
Ascension Texas Cardiovascular	Austin	Texas	In reclutamento
Massachusetts General Hospital	Boston	Massachusetts	In reclutamento
Brigham and Women's Hospital	Boston	Massachusetts	In reclutamento
Ascension St. Vincent Heart Center	Carmel	Indiana	In reclutamento
Novant Health	Charlotte	North Carolina	In reclutamento
University of Virginia	Charlottesville	Virginia	In reclutamento
Northwestern University	Chicago	Illinois	In reclutamento
The Christ Hospital	Cincinnati	Ohio	In reclutamento
Cleveland Clinic	Cleveland	Ohio	In reclutamento
The Ohio State University	Columbus	Ohio	In reclutamento
Henry Ford St. Johns	Detroit	Michigan	In reclutamento
Henry Ford Hospital	Detroit	Michigan	In reclutamento
Medical City Fort Worth	Fort Worth	Texas	In reclutamento
The Cardiac and Vascular Institute	Gainesville	Florida	In reclutamento
Northeast Georgia	Gainsville	Georgia	In reclutamento
Corewell Health	Grand Rapids	Michigan	In reclutamento
Hackensack University	Hackensack	New Jersey	In reclutamento
Cardiovascular Institute of the South	Houma	Louisiana	In reclutamento
HCA Houston Healthcare Medical Center	Houston	Texas	Ritirato
University of Texas Health Science Center at Houston	Houston	Texas	In reclutamento
Texas Heart Institute	Houston	Texas	In reclutamento
Houston Methodist	Houston	Texas	In reclutamento

Nella scheda del registro sono indicati altri 46 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

12 agosto 2026
Centro aggiunto
1 site added (96 total)
9596

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05102019