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

NCT01732341 | Terminated Phase 3 DMC

• 1 other identifier: STENTYS
• Study Type: interventional
• Target: 318
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Acute Myocardial Infarction

Keywords

STEMI; BMS; Self-expanding stent

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure

  From date of randomization until the date of first documented TVF, assessed up to 12 months.

  12 months.

Secondary Outcomes (1)

• Acute Stent Malapposition

  Immediately after procedure

Study Arms (2)

STENTYS self-apposing stent

EXPERIMENTAL

Intervention to treat STEMI with the STENTYS self-apposing stent

Device: STENTYS self-apposing stent

VISION balloon-expandable stent

ACTIVE COMPARATOR

STEMI treatment with a VISION balloon-expandable stent

Device: VISION balloon-expandable stent

Interventions

STENTYS self-apposing stent DEVICE

Intervention to treat STEMI with the STENTYS self-apposing stent

STENTYS self-apposing stent

VISION balloon-expandable stent DEVICE

STEMI treatment with a VISION balloon-expandable stent \--------------------------------------------------------------------------------

VISION balloon-expandable stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

• 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.

Sponsors & Collaborators

• Stentys: lead

Study Sites (3)

Foundation Cardiovascular medicine

La Jolla, California, 92037, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

AMC

Amsterdam, Netherlands

Location

Related Publications (1)

• Grundeken MJ, Lu H, Mehran R, Cutlip DE, Leon MB, Yeung A, Koch KT, Montalescot G, van Geuns RJ, Spaargaren R, Buchbinder M. APPOSITION V: STENTYS coronary stent system clinical trial in subjects with ST-segment elevation myocardial infarction--rationale and design. Am Heart J. 2014 Nov;168(5):652-60. doi: 10.1016/j.ahj.2014.07.011. Epub 2014 Jul 24.

  PMID: 25440792 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Roxana Mehran, MD

  Mount Sinai Hospital, New York NY

  PRINCIPAL INVESTIGATOR

• Maurice Buchbinder, MD

  Fouyndation Cardiovascular Research, La Jolla, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 22, 2012
• Study Start: May 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2017
• Last Updated: April 20, 2017

Record last verified: 2015-11

Locations

NL (1); US (2)