Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent

Last updated: April 23, 2018
Sponsor: UMC Utrecht
Overall Status: Active - Recruiting

Phase

4

Condition

Acute Pain

Cardiovascular Disease

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT02328898
14-244/M
  • Ages > 18
  • All Genders

Study Summary

The study objective is to assess the safety and efficacy of the Permanent Polymer Zotarolimus-Eluting Stent Resolute Integrity™ to the Polymer Free Amphilimus-Eluting Stent Cre8™ compared in an all-comer patient population. 1 month of dual antiplatelet duration will be applied in stable angina pectoris patients. Myocardial infarction patient population will be treated with 12 months of dual antiplatelet therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria: General Inclusion Criteria:

  1. All-comer patients aged 18 years and older

  2. Patient has been informed of the nature of the trial and agrees to its provisions andhas provided either oral during emergency procedure, followed by written informedconsent, or written informed consent in case of an elective procedure as approved bythe Medical Research Ethics Committee (MREC) of the respective investigational site

  3. Patient is eligible, according to heart team decision if applicable, for PCI withimplantation of a drug-eluting stent (DES)

  4. Patient has clinical evidence of ischemic heart disease, angina pectoris, myocardialinfarction, or silent ischemia Angiographic Inclusion Criteria:

  5. All de-novo lesions and all restenotic lesions (whether native coronary or bypassgraft), not amenable for treatment with drug eluting balloons

  6. All lesions types are allowed: calcified lesions (lesion preparation withscoring/cutting and rotational atherectomy are allowed), thrombus, chronic totalocclusion (CTO; randomized after successful wire crossing and pre-dilatation),bifurcation lesions, ostial lesions, bypass graft (venous and arterial) lesions andleft main.

  7. There is no limit for lesion length; overlapping stents are allowed, or number oflesions or diseased vessels.

  8. Target vessel size reference (visual estimation) between 2.5 mm and 4.5 mm.

Exclusion

Exclusion Criteria:

  1. Inability to provide informed consent

  2. Participation in another study for intracoronary stents that had not reached itsprimary endpoint

  3. Planned surgery within the next 3 months

  4. Known intolerance to P2Y12 receptor antagonist that would prevent adherence to DAPT,or intolerance to aspirin, clopidogrel, Ticagrelor, Prasugrel, heparin/bivalirudin,contrast agent (that cannot be adequately premedicated) or component of DES

  5. Female of childbearing potential, who are pregnant or are planning to become pregnant

  6. Life expectancy of less than 12 months

Study Design

Total Participants: 1532
Study Start date:
November 01, 2014
Estimated Completion Date:
September 30, 2020

Study Description

A Prospective, Multi-Center, Open Label, Randomized Controlled, two-arm Study to Evaluate the Safety and Efficacy of the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™' Compared to Polymer Free Amphilimus Eluting Stent 'Cre8'. Dual Antiplatelet Therapy duration of 1 Month will be applied in stable angina pectoris patient population. Myocardial infarction patient population will be treated with 12 months of dual antiplatelet therapy (DAPT).

One thousand five hundred thirty-two (1532) patients (1:1 randomization Cre8 stent: Resolute Integrity™ stent) will be enrolled in the study, with clinical follow-up at 12 months to assess the primary end point.

After a period of 12 months, a clinical registry will be implemented Information will be collected at 3-years post procedure.

Connect with a study center

  • Institute of Cardiac Surgery and Interventional Cardiology

    Luxembourg,
    Luxembourg

    Active - Recruiting

  • Zuyderland Medical Centre

    Heerlen,
    Netherlands

    Active - Recruiting

  • UMC Utrecht

    Utrecht, 3584CM
    Netherlands

    Active - Recruiting

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