NCT02328898

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,532 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stable Angina Pectoris
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	Cre8 Stent	Comparison of the Resolute Integrity stent with the Cre8 stent.
DEVICE	Resolute Integrity stent

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-09-01
• Completion: 2020-09-01
• First posted: 2014-12-31
• Last updated: 2018-04-25

Locations

3 sites across 2 countries: Luxembourg, Netherlands