Last updated on April 2018

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


Brief description of study

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 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.

Clinical Study Identifier: NCT02328898

Contact Investigators or Research Sites near you

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Pieter R Stella, MD, PhD

UMC Utrecht
Utrecht, Netherlands
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Peter Frambach, MD

Institute of Cardiac Surgery and Interventional Cardiology
Luxembourg, Luxembourg
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Mera Stein, MD PhD

Zuyderland Medical Centre
Heerlen, Netherlands
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