This study will test compare the Stentys Stent with the Multi-Link Vision™ stent system
(Abbott Vascular Inc.)in patients with a heart attack. It is expected that the Stentys stent
is not worse than the Vision stent.
Device: STENTYS self-apposing stent
Device: VISION balloon-expandable stent
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Locations near you
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Full eligibility criteria for NCT01732341
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
General Inclusion Criteria
Subject ≥ 18 years old.
Subject experiencing clinical symptoms consistent with AMI of >30 min. in duration.
ST elevation ≥1 mm in ≥2 contiguous leads or new left bundle branch block, or true posterior MI with ST depression of ≥1 mm in ≥2 contiguous anterior leads.
Symptom duration is <12 hours prior to signing informed consent.
Subject should be in catheterization laboratory and procedure started within 2 hours of consent.
Patient provides written informed consent.
Patient agrees to all required follow-up procedures and visits. Angiographic Inclusion Criteria
Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting.
The vessel diameter is either known or expected to be 2.5-4.0mm, without excessive tortuosity or diffuse distal disease.
Lesion length ≥12mm and ≤ 23mm
General Exclusion Criteria
Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
Female patients of childbearing potential known to be pregnant.
Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or emergency IABP for hypotension).
The subject requires multivessel PCI at time of index procedure or any staged procedure of the target vessel within 9 months or any non-target vessel within 30 days post-procedure.
The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.). Thrombus aspiration may be used per operator discretion.
Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
Concurrent medical condition with a life expectancy of less than 12 months.
Known left ventricular ejection fraction (LVEF) < 25% at the most recent evaluation
(prior to the index hospitalization).
History of cerebrovascular accident or transient ischemic attack in the last 6 months.
Active peptic ulcer or active gastrointestinal (GI) bleeding.
History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, or sensitivity to contrast media, which cannot be adequately pre-medicated.
Known serum creatinine level > 2.5 mg/dl, eGFR <30, or hemodialysis dependent. Angiographic Exclusion Criteria
Unprotected left main coronary artery disease (obstruction greater than 60% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the left anterior descending (LAD) or left circumflex (LCX) artery or a branch thereof).
Multi-vessel intervention required during the index procedure.
All locations for NCT01732341
United States (2)
Foundation Cardiovascular medicine
La Jolla, California, United States, 92037
Mount Sinai Hospital
New York, New York, United States, 10029
View full eligibility
Tris trial is registered with FDA with number: NCT01732341. The sponsor of the trial is Stentys and it is looking for 318 volunteers for the current phase.
Official trial title: APPOSITION V: Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction
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