NCT07045194ClinicalTrials.gov

Virtue® SAB in the Treatment of Coronary ISR Trial

A Prospective, Multi-center, Single-blind, Randomized (1:1), Non-inferiority Study Comparing Clinical Outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the Treatment of Coronary Artery In-stent Restenosis (ISR).

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

A prospective, multi-center, single-blind, randomized (1:1), non-inferiority study comparing clinical outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).

Interventistico740 partecipanti ricercati15 centri1 paese

Categorie

Cardiovascolare100%

Registrato in 1 registro

ClinicalTrials.govNCT07045194Apri questa scheda su ClinicalTrials.govSincronizzato 2 mesi fa

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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 2025-07-01; recorded start 2025-10-20
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 1 other study in this databaseCounted from the lead sponsor named in the record (Orchestra BioMed, Inc)
Not stated: No posted results from this sponsor are in this database yetBased 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
Blinding7/20
Single-blind
Control arm15/15
Active-comparator 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: 15 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: 740 participants (target), run at 15 sites.

How this score is built

Enrolment28/40
740 participants (target)
Site count14/25
15 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 85 months
Sponsor scale1/10
Orchestra BioMed, Inc has led 2 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

The Virtue® ISR trial is a prospective, multi-center, single-blind, randomized (1:1), non-inferiority study. The Virtue® Sirolimus AngioInfusion™ Balloon (SAB) will be compared to the AGENT Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).

Patologie

Coronary Artery Disease

Idoneità

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

Idoneità come riportata nel registro

Inclusion Criteria: * In-stent restenosis (one or two stent layers) in a lesion previously treated with drug- eluting (DES) or bare metal stents (BMS) in a native coronary artery. * The target lesion has a reference vessel diameter ≥ 2.0 mm and ≤ 4.0 mm by visual assessment. * The subject has only one critical ISR lesion in the target vessel. * The subject may have one other critical lesion in a non-target vessel that must be treated before the Target Lesion (TL). * Target lesion length must be ≤ 26 mm and must be completely coverable by only one Virtue® or AGENT™ balloon. The balloon can extend up to 5 mm proximal or distal beyond the edge of the target stented length. * The target lesion must have one of the following: * Visually estimated stenosis of ≥ 70% and \<100% diameter stenosis, OR * Visually estimated stenosis ≥ 50% and \< 70% with one of the following: * abnormal fractional flow reserve (FFR) including Angio based FFR ≤ 0.80, or; * abnormal instantaneous wave-free ratio (iFR) or resting full-cycle ratio (RFR) ≤ 0.89, or; * abnormal stress or imaging stress test, or; * ischemic symptoms referable to the target lesion * Involved in a NSTEMI or Acute Coronary Syndrome (ACS) event with decreasing enzymes * Target lesion must be successfully pre-treated according to standard of care with an achieved residual stenosis of ≤ 30% by visual estimate with TIMI grade flow of 3 prior to randomization. Exclusion Criteria: * Subject has a left ventricular ejection fraction \< 30% within 6 months. * Subject was treated by PCI or another coronary intervention within the last 30 days. * Planned PCI or CABG after the index procedure. * Subjects with STEMI \< 72 hours prior to index procedure and those with NSTEMI who have increasing biomarkers within 12 hours of the index procedure. * If single-layer ISR, any previous treatment (other than balloon angioplasty alone) of the target vessel for restenosis. If double-layer ISR, any treatment (other than balloon angioplasty alone) of the double-layer ISR restenosis. * Target lesion is located within a saphenous vein graft or an arterial graft. * Thrombus is present in the target vessel. * \> 50% stenosis of an additional lesion proximal or clinically significant distal (\>2.0mm RVD) to the target lesion. * A dissection in the target lesion requiring treatment with a stent post pre-dilatation. * The target ISR lesion has more than two layers of previously placed stents. * Subject has critical unprotected left main coronary artery disease.

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	SINGLE (1)
Arruolamento	740 partecipanti ricercati

Sponsor e collaboratori

Orchestra BioMed, Inc Sponsor

Bracci e interventi

Virtue SABEXPERIMENTAL
Coronary PCI, Sirolimus AngioInfusion Balloon (SAB)
AGENT™ DCBACTIVE_COMPARATOR
Coronary Angioplasty, AGENT™ Paclitaxel Drug-Coated Balloon (DCB)

Interventi

Dispositivo AGENT™ Paclitaxel Drug-Coated Balloon
Percutaneous Coronary Intervention
Dispositivo Virtue Sirolimus AngioInfusion Balloon
Percutaneous Coronary Intervention

Esiti misurati

Esito primario
Target Lesion Failure (TLF) at 12 months
Defined as a composite of cardiac death (CD), non-fatal target vessel myocardial infarction (MI) SCAI definition, and ischema-driven target lesion revascularization (TLR)
Orizzonte temporale 12 months
Esito secondario
Target Lesion Failure (TLF) Comparison at 12 months
Target Lesion Failure (TLF) at 12 months of subjects treated with Virtue® SAB compared to a PBA Performance Goal.
Orizzonte temporale 12 months

Date

Date
Data di inizio	20 ottobre 2025 (effettiva)
Conclusione primaria	1 ottobre 2028 (stimata)
Conclusione	1 ottobre 2032 (stimata)
Prima pubblicazione	1 luglio 2025 (effettiva)
Ultimo aggiornamento	23 luglio 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	luglio 2026

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

Centri

15 centri stanno reclutando

United States

United States
Struttura	Città	Stato o regione	Stato
Mission Hospital	Asheville	North Carolina	In reclutamento
Ascension Saint Agnes Heart Care	Baltimore	Maryland	In reclutamento
The Lindner Center for Research at Christ Hospital	Cincinnati	Ohio	In reclutamento
The Cardiac and Vascular Institute	Gainesville	Florida	In reclutamento
Ascension St. Vincent	Indianapolis	Indiana	In reclutamento
Ascension Seton Hays	Kyle	Texas	In reclutamento
Ascension Columbia St. Mary's Hospital	Milwaukee	Wisconsin	In reclutamento
TriStar Centennial Medical Center	Nashville	Tennessee	In reclutamento
Ascension St. Thomas Hospital	Nashville	Tennessee	In reclutamento
Ascension Sacred Heart	Pensacola	Florida	In reclutamento
Thomas Jefferson University	Philadelphia	Pennsylvania	In reclutamento
St. Francis Hospital	Roslyn	New York	In reclutamento
Corewell Health William Beaumont University Hospital	Royal Oak	Michigan	In reclutamento
Ascension Via Christi Saint Francis	Wichita	Kansas	In reclutamento
WellSpan Health	York	Pennsylvania	In reclutamento

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

https://xmedica.io/trials/ctgov/NCT07045194