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

Phase 4

• Conditions: Acute Coronary Syndrome; Stable Angina Pectoris
• Interventions: Device: Cre8 Stent; Device: Resolute Integrity stent

• Registration Number: NCT02328898
• Lead Sponsor: UMC Utrecht

Brief 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.

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.

Study Timeline

• Study First Submitted: 2014-09-16
• Study Start: 2014-11
• Study First Submitted QC: 2014-12-30
• Study First Posted: 2014-12-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-25
• Primary Completion: 2018-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1532

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cre8 stent	Cre8 Stent	PCI with the Polymer Free Amphilimus Eluting Stent 'Cre8™'
Resolute Integrity Stent	Resolute Integrity stent	Comparison of the Cre8 stent with the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™'

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	12 and 36 months	Cardiac death, vessel-related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI

Secondary Outcome Measures

Name	Time	Method
Device, lesion and procedure success at time of baseline procedure	12 and 36 months
Net Adverse Clinical Events (NACE)	12 and 36 months	defined as composite of any death, stroke, myocardial infarction, any unplanned repeated revascularization and bleeding (BARC 3a and above)
Target lesion failure (TLF)	12 and 36 months	separate components of the primary endpoint; cardiac death, vessel related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI
Target vessel revascularization by CABG or PCI (TVR)	12 and 36 months
Stent thrombosis	12 and 36 months

Trial Locations

Locations (3)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

Institute of Cardiac Surgery and Interventional Cardiology; 🇱🇺 Luxembourg, Luxembourg

Zuyderland Medical Centre; 🇳🇱 Heerlen, Netherlands