Have you or your loved ones been diagnosed with acute coronary syndrome?

You may be eligible to participate in a acute coronary syndrome clinical trial.

Have you or your loved ones been diagnosed with acute coronary syndrome? You may be eligible to participate in a acute coronary syndrome clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Acute Coronary Syndrome Clinical Trial in Luxembourg

NCT02328898 | Phase 4 | Interventional

Have you or your loved ones been diagnosed with acute coronary syndrome?

You may be eligible to participate in a acute coronary syndrome clinical trial.

Have you or your loved ones been diagnosed with acute coronary syndrome? You may be eligible to participate in a acute coronary syndrome clinical trial.

Recruiting

Male & Female

18 Years +

This study is looking to recruit 1532 Participants

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.

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Details for the study

Brief Title

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

Official Title

A Prospective, Multi-Center, Open Label, Randomized Controlled, Two Arm Study Evaluating Safety and Efficacy of the Permanent Polymer Zotarolimus Eluting Stent Resolute Integrity Compared to the Polymer Free Amphilimus Eluting Stent Cre8

Brief Summary

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

Detailed 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.

Treatments and/or Procedures

Cre 8 stent

Comparison of the Resolute Integrity stent with the Cre8 stent.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Target Lesion Failure (TLF)

Cardiac death, vessel-related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI

12 and 36 months

Secondary

Target lesion failure (TLF)

separate components of the primary endpoint; cardiac death, vessel related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI

12 and 36 months

Secondary

Net Adverse Clinical Events (NACE)

defined as composite of any death, stroke, myocardial infarction, any unplanned repeated revascularization and bleeding (BARC 3a and above)

12 and 36 months

Study Criteria

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 and
has provided either oral during emergency procedure, followed by written informed
consent, or written informed consent in case of an elective procedure as approved by
the Medical Research Ethics Committee (MREC) of the respective investigational site

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

4. Patient has clinical evidence of ischemic heart disease, angina pectoris, myocardial
infarction, or silent ischemia

Angiographic Inclusion Criteria:

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

2. All lesions types are allowed: calcified lesions (lesion preparation with
scoring/cutting and rotational atherectomy are allowed), thrombus, chronic total
occlusion (CTO; randomized after successful wire crossing and pre-dilatation),
bifurcation lesions, ostial lesions, bypass graft (venous and arterial) lesions and
left main.

3. There is no limit for lesion length; overlapping stents are allowed, or number of
lesions or diseased vessels.

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

Exclusion Criteria:

1. Inability to provide informed consent

2. Participation in another study for intracoronary stents that had not reached its
primary 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