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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome; Stable Angina Pectoris
• Intervention / Treatment: Device: Cre8 Stent; Device: Resolute Integrity stent

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 Type: Interventional
• Enrollment (Anticipated): 1532
• Phase: Phase 4

Contacts and Locations

Study Locations

• Luxembourg
  • Luxembourg, Luxembourg
    • Recruiting
    • Institute of Cardiac Surgery and Interventional Cardiology
    • Contact: Peter Frambach, MD
• Netherlands
  • Heerlen, Netherlands
    • Recruiting
    • Zuyderland Medical Centre
    • Contact: Mera Stein, MD PhD
  • Utrecht, Netherlands, 3584CM
    • Recruiting
    • UMC Utrecht
    • Contact: Pieter R Stella, MD, PhD; Phone Number: +31-88-7556167; Email: p.stella@umcutrecht.nl
    • Sub-Investigator: Rik Rozemeijer, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cre8 stent; PCI with the Polymer Free Amphilimus Eluting Stent 'Cre8™'	Device: Cre8 Stent; Comparison of the Resolute Integrity stent with the Cre8 stent.; Other Names: Resolute Integrity Stent
Active Comparator: Resolute Integrity Stent; Comparison of the Cre8 stent with the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™'	Device: Resolute Integrity stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Target vessel revascularization by CABG or PCI (TVR)		12 and 36 months
Stent thrombosis		12 and 36 months
Device, lesion and procedure success at time of baseline procedure		12 and 36 months

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: Pieter R Stella, M.D., PhD, UMC Utrecht, The Netherlands

Publications and helpful links

General Publications

• van Hemert ND, Voskuil M, Rozemeijer R, Stein M, Frambach P, Pereira B, Rittersma SZ, Kraaijeveld AO, Leenders GEH, Timmers L, van der Harst P, Agostoni P, Stella PR; ReCre8 Study Investigators. 3-Year Clinical Outcomes After Implantation of Permanent-Polymer Versus Polymer-Free Stent: ReCre8 Landmark Analysis. JACC Cardiovasc Interv. 2021 Nov 22;14(22):2477-2486. doi: 10.1016/j.jcin.2021.08.078.
• Rozemeijer R, Stein M, Voskuil M, van den Bor R, Frambach P, Pereira B, Koudstaal S, Leenders GE, Timmers L, Rittersma SZ, Kraaijeveld AO, Agostoni P, Roes KC, Doevendans PA, Stella PR; ReCre8 Study Investigators. Randomized All-Comers Evaluation of a Permanent Polymer Zotarolimus-Eluting Stent Versus a Polymer-Free Amphilimus-Eluting Stent. Circulation. 2019 Jan 2;139(1):67-77. doi: 10.1161/CIRCULATIONAHA.118.037707.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: December 30, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; Polymer free stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Acute Coronary Syndrome; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: 14-244/M