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Acute Myocardial InfarctionPhase 3APPOSITION VNCT01732341

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

A Phase 3 study testing STENTYS self-apposing stent and VISION balloon-expandable stent in people with Acute Myocardial Infarction, run by Stentys at 3 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
STENTYS self-apposing stent and VISION balloon-expandable stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
3 sitesin 2 countries
Study dates
May 2013to Mar 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • -

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Foundation Cardiovascular medicine

    La Jolla, California, 92037

  • Mount Sinai Hospital

    New York, New York, 10029

Other trials in United States

Netherlands1 site

  • AMC

    Amsterdam

Other trials in Netherlands

About this study

Official title: APPOSITION V: Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction

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.

Read the 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.

Being tested
STENTYS self-apposing stent, VISION balloon-expandable stent
Keywords
STEMI, BMS, Self-expanding stent
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STENTYS self-apposing stentDevice

    Intervention to treat STEMI with the STENTYS self-apposing stent

  • VISION balloon-expandable stentDevice

    STEMI treatment with a VISION balloon-expandable stent

    --------------------------------------------------------------------------------

Study groups in NCT01732341
Study groupRoleWhat they receive
STENTYS self-apposing stentExperimentalIntervention to treat STEMI with the STENTYS self-apposing stent
Receives: Device: STENTYS self-apposing stent
VISION balloon-expandable stentActive comparatorSTEMI treatment with a VISION balloon-expandable stent
Receives: Device: VISION balloon-expandable stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Vessel Failure

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

    Measured: 12 months.

Secondary outcomes (1)

  1. Acute Stent Malapposition

    Measured: Immediately after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2012 (estimated)
  2. Study startMay 2013
  3. Primary completionDec 2015
  4. Study completionMar 2017

Why it stopped: Decision to discontinue patient follow-up at 2 years.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01732341
Sponsor's protocol ID
STENTYS
Acronym
APPOSITION V
Status last verified
Nov 2015
First submitted
2 Nov 2012
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25440792

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing STENTYS self-apposing stent and VISION balloon-expandable stent in people with Acute Myocardial Infarction, run by Stentys at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Decision to discontinue patient follow-up at 2 years.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Vessel Failure (time frame: 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01732341, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.

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