STENTYS Self-expanding Versus Balloon-expandable Stent in Acute Myocardial Infarction (AMI) (APPOSITION ll)

January 21, 2011 updated by: Stentys

Randomized Comparison Between the STENTYS Self-expanding Coronary Stent and a Balloon-expandable Stent in Acute Myocardial Infarction - APPOSITION II

Study hypothesis: the Stentys self-expandable Stent results into a better alignment of the struts to the vessel wall than a balloon-expandable stent within a few days after the procedure in acute myocardial infarction patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stent strut malapposition and stent underexpansion are a common phenomenon in AMI as a result of the changing anatomy after an AMI has occurred (thrombus dissolution, resolution of spasm) with the traditional balloon-expandable stent treatment. A self-expanding stent might lead to better stent strut apposition as it follows the contours of the vessel wall due to its self-expanding properties. This might result into better long term clinical outcomes like lower thrombosis rates.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • C. Spaulding

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject 18 years old.

  2. Acute Myocardial Infarction defined as presence of at least two of the three items below:

    1. Detection of rise of cardiac biomarkers with a least one value above the 99th percentile of the upper reference limit (URL)
    2. Symptoms of ischaemia (chest pain) >20 minutes
    3. ECG changes indicative of new ischaemia: new ST-T changes (ST deviation ≥0.2mV precordial leads and/or ≥0.1mV limb leads) or new LBBB)
  3. Reperfusion expected to be achieved within 12 hours from the onset of symptoms
  4. Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
  5. Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone.
  6. Acceptable candidate for coronary artery bypass graft (CABG) surgery.
  7. Male or non-pregnant female subject.

Angiographic Inclusion Criteria:

  1. Reference vessel diameter >2.5mm and <4.0mm by visual estimate.
  2. Target lesion <30mm in length by visual estimate

Exclusion Criteria:

  1. Currently enrolled in another investigational device or drug study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
  2. Coronary or cardiac intervention or major surgery of any kind within 30 days prior to the procedure.
  3. Target vessel supplied by by-pass vessel
  4. Patients on anticoagulation therapy (Coumadin)
  5. Patient received thrombolytic therapy.
  6. Myocardial infarction due to stent thrombosis, or infarct lesion at the side of a previously implanted stent
  7. Cardiogenic shock
  8. Any previous stent placement within 10mm (proximal or distal) of the target lesion.
  9. Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study.
  10. Concurrent medical condition with a life expectancy of less than 6 months.
  11. Left ventricular ejection fraction (LVEF) <30% at the most recent evaluation.
  12. Cerebrovascular accident or transient ischemic attack in the last 6 months.
  13. 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.
  14. Known serum creatinine level >2.5mg/dl or presence or history of renal failure

Angiographic Exclusion Criteria:

  1. Unprotected left main coronary artery disease (obstruction greater than 50% 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. Target vessel is excessively tortuous (two bends >90˚ to reach the target lesion).
  3. Lesion location that is aorto-ostial or within 5mm of the origin of the LAD or LCX.
  4. Target lesion is severely calcified.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-expanding stent
Stentys stent
Device: Stentys coronary stent
Self-expanding Nitinol stent
Other Names:
  • Self-expanding stent
Active Comparator: Balloon-expandable stent
VISION/Driver
Device: Balloon-expandable stent
VISION/Driver
Other Names:
  • VISION/Driver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stent strut apposition measured by optical coherence tomography (OCT)
Time Frame: 3 days after procedure
3 days after procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Stent thrombosis
Time Frame: 30 days and 6 months
30 days and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stentys

Investigators

  • Principal Investigator: Stefan Verheye, MD, Ph.D, ZNA, Middelheim, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 4, 2009

First Submitted That Met QC Criteria

November 4, 2009

First Posted (Estimate)

November 5, 2009

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST2009-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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