Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction

Stopped early · Phase 3

Conditions studied: Acute Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT01732341

Run by

Stentys

People needed

318

Starts

2013-05-01

Expected to finish

2017-03-01

Last updated by the study team

2017-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Patients undergoing cardiopulmonary resuscitation.
• 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.
• Attempted thrombolysis.
• 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.

Where it is running

• Foundation Cardiovascular medicine — La Jolla, California, United States
• Mount Sinai Hospital — New York, New York, United States
• AMC — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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