NCT06779630ClinicalTrials.gov

Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

A Prospective Multicenter Single Arm Study to Assess the Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System for the Treatment of Subjects With Atherosclerotic Lesion(s)

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

התערבותידרושים 150 משתתפים23 אתרים6 מדינות

קטגוריות

לב וכלי דם100%

רשום במרשם אחד

ClinicalTrials.govNCT06779630פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני חודשיים

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

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התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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 2025-01-16; recorded start 2025-07-18
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
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
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 3 other studies in this databaseCounted from the lead sponsor named in the record (Teleflex)
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 rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
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: 23 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleSMALL

A small study, international in scope: 150 participants (target), run at 23 sites, across 6 countries.

How this score is built

Enrolment21/40
150 participants (target)
Site count16/25
23 sites
Country count12/15
6 countries
Planned duration10/10
Planned over about 75 months
Sponsor scale2/10
Teleflex has led 4 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.

תקציר

The purpose of the study is to assess the safety and efficacy of the Orsiro® Mission 48- mm Sirolimus-Eluting Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) \>36 mm and ≤ 44 mm in length (by visual estimate) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm. Patients enrolled in the United States will be followed for 2 years post index procedure with follow-up visits at 1, 6, 12 months and 2 years post index procedure. Patients enrolled outside of the United States will be followed through 5 years post index procedure with additional follow-up visits at 3 and 5 years post index procedure.

מצבים רפואיים

Coronary Artery Disease

זכאות

זכאות
מין	הכול
גילאים	18 Years – ללא מקסימום
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

Inclusion Criteria: 1. Subject is ≥ 18 years of age 2. Subject is able to understand the nature of the study and provide written informed consent. For sites outside of the United States: Note: For subjects presenting with STEMI and not in a position to read, interpret and sign the informed consent form, oral informed consent is required. 3. Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines. 4. Subject is an acceptable candidate for CABG. 5. Subject is eligible for dual antiplatelet therapy (DAPT) according to guidelines. 6. Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia. 7. Subject is willing and able to comply with study follow-up requirements. Angiographic inclusion criteria: 1. Subject has only one target lesion in a native coronary artery to be treated with the investigational device. Note: One additional non-target lesion may be treated with a non-investigational treatment (e.g. stent, balloon angioplasty, atherectomy) with the exception of brachytherapy, if it is located in a different coronary artery. The non-target lesion must be treated first and must be deemed an angiographic success. (Angiographic success is defined by a residual diameter stenosis \< 30% with TIMI 3 flow, as visually assessed by the physician, without the presence of prolonged chest pain or ECG changes consistent with MI.) Note: Multiple focal stenoses will be considered as a single lesion if they are amenable to treatment with a single study device. 2. Target lesion must be \> 36 mm and ≤ 44 mm in length by operator visual estimate and must be amenable to treatment with a single study device. 3. Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate. 4. For sites in United States: Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only. For sites outside of the United States: Target lesion can be de novo, restenotic or in-stent restenotic, and must be located in a native coronary artery. 5. Target lesion must have angiographic evidence of ≥ 50% and \< 100% stenosis (by operator visual estimate which may be assisted by QCA / IVUS / OCT). Target lesion stenosis \< 70% should have clinical justification for treatment as per local standards. 6. Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow \> 1. For sites outside of the United States: Note: For STEMI, TIMI flow \> 1 prior to stent implantation (after opening the vessel with a guide wire or a balloon). Exclusion Criteria: 1. For sites in United States only: Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment. 2. Subject is hemodynamically unstable. 3. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study. 4. Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), acrylic, fluoropolymers, silicon carbide, PLLA or sirolimus. 5. Revascularization of any target vessel within 12 months prior to the index procedure or previous PCI of any non-target vessel within \<72 hours prior to the index procedure. 6. Future planned PCI (including staged procedure) or CABG after the index procedure. 7. Planned surgery or dental surgical procedure within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period. 8. History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure. 9. Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT. 10. Subject will refuse blood transfusions. 11. Subject has a left ventricular ejection fraction (LVEF) \< 30% within 6 months prior to or during the index procedure that was documented by any method. 12. Subject is dialysis dependent or has impaired renal function (i.e., serum creatinine \> 2.5 mg/dL or 221 µmol/L, determined within 7 days prior to the index procedure). 13. Subject has a documented white blood cell count \< 3,000 white blood cells/mm3 or a documented platelet count \< 100,000 platelets/mm3 or \> 700,000 platelets/mm3. 14. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted). 15. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure or has a malignancy that is not in remission. 16. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained according to guidelines. 17. Subject has life expectancy of \< 1 year. 18. Subject is currently participating or plans to participate in another clinical investigation with an investigational device or an investigational drug. 19. In the investigator's opinion, subject will not be able to comply with the follow-up requirements. Angiographic exclusion criteria: 1. Target lesion is excluded if it meets any of the following criteria: 1. Lesion is located within or treated through a saphenous vein graft or arterial graft. 2. Lesion location is within the left main coronary artery. 3. Lesion location is within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX) coronary arteries. 4. Involves a side branch of \> 2.0 mm in diameter that requires a two-device strategy after pre-dilatation. 5. Lesion is totally occluded (100% stenosis). 6. For sites in United States only: Lesion is a restenotic lesion that was previously treated with a bare metal or drug eluting stent (in-stent restenosis). 2. Target vessel/lesion is excessively tortuous/angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation. 3. Site sites in the United States: Target vessel has angiographic evidence of thrombus. For sites outside of the United States: Target vessel has angiographic evidence of unresolved large thrombus burden despite of thrombus aspiration. Note: Thrombus aspiration is left at the discretion of the implanting physician. 4. Target vessel was treated with brachytherapy any time prior to the index procedure. 5. Unsuccessful target lesion pre-dilatation, defined as residual stenosis \> 50% (by visual estimation) and/or angiographic complications (e.g., distal embolization, side branch closure, dissection greater than National Heart, Lung, Blood Institute type C), and/or, for sites outside of the United States, coronary aneurysms. 6. Non-target lesion is excluded if it meets any of the following criteria: 1. Any of the target lesion angiographic exclusion criteria except for 1c 2. Lesion is located within the target vessel. 3. Lesion is \> 36 mm by operator visual estimate. 4. Lesion requires additional, unplanned stents to treat a complication. 5. Lesion treatment is not deemed an angiographic success. (Angiographic success is defined by a residual diameter stenosis \< 30% with TIMI 3 flow, as visually assessed by the physician, without the presence of prolonged chest pain or ECG changes consistent with MI.)

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	לא רלוונטי
הקצאה	לא רלוונטי
מודל ההתערבות	SINGLE_GROUP
מטרה ראשית	TREATMENT
הסתרה	NONE (0)
גיוס	דרושים 150 משתתפים

נותן חסות ושותפים

Teleflex נותן חסות
BIOTRONIK AG (A Teleflex Company) שותפים

זרועות והתערבויות

Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent SystemEXPERIMENTAL

התערבויות

התקן Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System
Orsiro Mission is composed of a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.

מדדי תוצאה

מדד תוצאה ראשוני
Target Lesion Failure (TLF) rate at 12 months post-index procedure
The primary endpoint will be target lesion failure (TLF) rate at 12 months post-index procedure. TLF is defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR).
מסגרת זמן 12 months
מדד תוצאה משני
Stent thrombosis
Stent thrombosis will be assessed according to Academic Research Consortium - 2 (ARC-2) definitions.
מסגרת זמן 1, 6, 12 months and 2, 3, and 5 years post-index procedure
מדד תוצאה משני
Device success
Device success, defined as attainment of \< 30% residual stenosis of the target lesion (based on operator visual estimate) using the Orsiro Mission study stent only.
מסגרת זמן Hospital Discharge (6-24 hours post-index procedure)
מדד תוצאה משני
Procedure success
Procedure success, defined as attainment of \< 30% residual stenosis of the target lesion (based on operator visual estimate) using the Orsiro Mission study stent only without occurrence of in-hospital major adverse cardiac events (MACE).
מסגרת זמן Hospital Discharge (6-24 hours post-index procedure)
מדד תוצאה משני
All-cause death
מסגרת זמן 1, 6, 12 months and 2, 3, and 5 years post-index procedure
מדד תוצאה משני
Any myocardial infarction (MI)
מסגרת זמן 1, 6, 12 months and 2, 3, and 5 years post-index procedure
מדד תוצאה משני
Cardiac death or myocardial infarction (MI)
מסגרת זמן 1, 6, 12 months and 2, 3, and 5 years post-index procedure
מדד תוצאה משני
Major cardiac adverse events (MACE) and individual MACE components
MACE is defined as a composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically driven target lesion revascularization (TLR).
מסגרת זמן 1, 6, 12 months and 2, 3, and 5 years post-index procedure
מדד תוצאה משני
Target lesion failure (TLF) and individual TLF components
TLF is defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR).
מסגרת זמן 1, 6, 12 months and 2, 3, and 5 years post-index procedure
מדד תוצאה משני
Target vessel failure (TVF) and individual TVF components
TVF is defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (TV-MI), and clinically driven target vessel revascularization (CD-TVR).
מסגרת זמן 1, 6, 12 months and 2, 3, and 5 years post-index procedure
מדד תוצאה משני
Target lesion revascularization (TLR)
מסגרת זמן 1, 6, 12 months and 2, 3, and 5 years post-index procedure
מדד תוצאה משני
Target vessel revascularization (TVR)
מסגרת זמן 1, 6, 12 months and 2, 3, and 5 years post-index procedure

תאריכים

תאריכים
תאריך התחלה	18 ביולי 2025 (בפועל)
סיום ראשוני	1 בספטמבר 2027 (משוער)
סיום	1 בספטמבר 2031 (משוער)
פורסם לראשונה	16 בינואר 2025 (בפועל)
עודכן לאחרונה	24 ביולי 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	ינואר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

10 אתרים מגייסים

Austria

Austria
מתקן	עיר	מדינה או אזור	מצב
Klinische Abteilung für Kardiologie, Medizinische Universität Graz	Graz	Styria	פעיל, ללא גיוס
Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie, Medizinische Universität Wien	Vienna	State of Vienna	פעיל, ללא גיוס

France

France
מתקן	עיר	מדינה או אזור	מצב
Clinique Louis Pasteur	Essey-lès-Nancy	Grand Est	פעיל, ללא גיוס
Hospices Civils de Lyon - CHU de Lyon	Lyon	Auvergne-Rhône-Alpes	פעיל, ללא גיוס
Hôpital Cochin - Groupe AP-HP	Paris	Île-de-France Region	פעיל, ללא גיוס
Institut Arnault Tzanck	Saint-Laurent-du-Var	Provence-Alpes-Côte d'Azur Region	פעיל, ללא גיוס

Germany

Germany
מתקן	עיר	מדינה או אזור	מצב
Segeberger Kliniken GmbH	Bad Segeberg	Schleswig-Holstein	פעיל, ללא גיוס
Klinikum Fürth	Fürth	Bavaria	פעיל, ללא גיוס
Universitätsklinikum Mannheim, I. Medizinische Klinik	Mannheim	Baden-Wurttemberg	פעיל, ללא גיוס
Universitätsklinikum Würzburg	Würzburg	Bavaria	פעיל, ללא גיוס

Poland

Poland
מתקן	עיר	מדינה או אזור	מצב
Miedziowe Centrum Zdrowia SA	Lubin	Lower Silesian Voivodeship	פעיל, ללא גיוס

Switzerland

Switzerland
מתקן	עיר	מדינה או אזור	מצב
University hospital Basel	Basel	Canton of Basel-City	פעיל, ללא גיוס
Istituto Cardiocentro Ticino	Lugano	Canton Ticino	פעיל, ללא גיוס

United States

United States
מתקן	עיר	מדינה או אזור	מצב
Massachusetts General Hospital	Boston	Massachusetts	מגייס
Charleston Area Medical Center	Charleston	West Virginia	מגייס
John Muir Medical Center	Concord	California	מגייס
Baylor Scott & White The Heart Hospital - Dallas	Dallas	Texas	מגייס
Henry Ford Hospital	Detroit	Michigan	מגייס
Ascension Texas Cardiovascular	Kyle	Texas	מגייס
North Shore University Hospital	Manhasset	New York	מגייס
Columbia University Irving Medical Center/New York Presbyterian Hospital	New York	New York	מגייס
Barnes Jewish Hospital	St Louis	Missouri	מגייס
Ascension Via Christi Hospitals Wichita	Wichita	Kansas	מגייס

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

24 ביולי 2026
אתר נוסף
1 site added (23 total)
2223

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06779630