Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction (APPOSITION V)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Stentys
Sponsor:
Information provided by (Responsible Party):
Stentys
ClinicalTrials.gov Identifier:
NCT01732341
First received: November 2, 2012
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Device: STENTYS self-apposing stent
Device: VISION balloon-expandable stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: APPOSITION V: Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Stentys:

Primary Outcome Measures:
  • Target Vessel Failure [ Time Frame: 12 months. ] [ Designated as safety issue: Yes ]
    From date of randomization until the date of first documented TVF, assessed up to 12 months.


Secondary Outcome Measures:
  • Acute Stent Malapposition [ Time Frame: Immediately after procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 880
Study Start Date: May 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STENTYS self-apposing stent
Intervention to treat STEMI with the STENTYS self-apposing stent
Device: STENTYS self-apposing stent
Intervention to treat STEMI with the STENTYS self-apposing stent
Active Comparator: VISION balloon-expandable stent
STEMI treatment with a VISION balloon-expandable stent
Device: VISION balloon-expandable stent

STEMI treatment with a VISION balloon-expandable stent

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Detailed Description:

Coronary artery disease continues to be the most common cause of morbidity and mortality in the occidental world. Treatment of coronary atherosclerotic disease has been significantly advanced by interventional cardiology, and in particular the advent of coronary arterial stents. In comparison to angioplasty alone, stents have reduced the incidence of angiographic as well as clinical restenosis, the recurrence of angina, the need for coronary arterial bypass graft (CABG) surgery, the need for repeat revascularization and the occurrence of major adverse cardiac events (MACE).However,problems remain due to failure to achieve optimal stent apposition and normal myocardial reperfusion. Early stent malapposition may be due to incomplete expansion or undersizing of balloon-expandable stents. Several studies have emphasized the importance of early malapposition in the setting of ST elevation MI, in which substantial thrombotic burden and the presence of diffuse vasoconstriction may be contributory. The Stentys Coronary Stent System includes a self-expanding bare metal (nitinol) stent on a rapid exchange (RX) delivery system. In view of the theoretical implications of malapposition, the self-expanding property may offer a potential benefit.

This study is designed to evaluate the safety and effectiveness of the Stentys Coronary Stent System in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary revascularization due to AMI as compared to the Multi-Link Vision™ coronary stent system (Abbott Vascular Inc. The study is powered for non-inferiority of the Stentys Coronary Stent System compared to the Vision Stent System.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

General Inclusion Criteria

  1. Subject ≥ 18 years old.
  2. Subject experiencing clinical symptoms consistent with AMI of >30 min. in duration.
  3. 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.
  4. Symptom duration is <12 hours prior to signing informed consent.
  5. Subject should be in catheterization laboratory and procedure started within 2 hours of consent.
  6. Patient provides written informed consent.
  7. Patient agrees to all required follow-up procedures and visits.

Angiographic Inclusion Criteria

  1. Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting.
  2. The vessel diameter is either known or expected to be 2.5-4.0mm, without excessive tortuosity or diffuse distal disease.
  3. Lesion length ≥12mm and ≤ 23mm

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Exclusion Criteria:

General Exclusion Criteria

  1. 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.
  2. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
  3. Female patients of childbearing potential known to be pregnant.
  4. Patients undergoing cardiopulmonary resuscitation.
  5. Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or emergency IABP for hypotension).
  6. 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.
  7. 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.
  8. Attempted thrombolysis.
  9. 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.
  10. Concurrent medical condition with a life expectancy of less than 12 months.
  11. Known left ventricular ejection fraction (LVEF) < 25% at the most recent evaluation (prior to the index hospitalization).
  12. History of cerebrovascular accident or transient ischemic attack in the last 6 months.
  13. Active peptic ulcer or active gastrointestinal (GI) bleeding.
  14. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
  15. 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.
  16. Known serum creatinine level > 2.5 mg/dl, eGFR <30, or hemodialysis dependent.

Angiographic Exclusion Criteria

  1. 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).
  2. Multi-vessel intervention required during the index procedure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732341

Contacts
Contact: René Spaargaren, MD +33 686 3005 19 rspaargaren@stentys.com

Locations
United States, California
Foundation Cardiovascular medicine Not yet recruiting
La Jolla, California, United States, 92037
Principal Investigator: Maurice Buchbinder, MD         
United States, New York
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Principal Investigator: Roxana Mehran, MD         
Netherlands
AMC Recruiting
Amsterdam, Netherlands
Contact: Karel Koch, MD         
Principal Investigator: Karel Koch, MD         
Sponsors and Collaborators
Stentys
Investigators
Principal Investigator: Roxana Mehran, MD Mount Sinai Hospital, New York NY
Principal Investigator: Maurice Buchbinder, MD Fouyndation Cardiovascular Research, La Jolla, CA
  More Information

No publications provided

Responsible Party: Stentys
ClinicalTrials.gov Identifier: NCT01732341     History of Changes
Other Study ID Numbers: STENTYS
Study First Received: November 2, 2012
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Stentys:
STEMI
BMS
Self-expanding stent

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014