Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent
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|ClinicalTrials.gov Identifier: NCT02328898|
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stable Angina Pectoris Acute Coronary Syndrome||Device: Cre8 Stent Device: Resolute Integrity stent||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||1532 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2020|
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 Name: 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
- Target Lesion Failure (TLF) [ Time Frame: 12 and 36 months ]Cardiac death, vessel-related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI
- Net Adverse Clinical Events (NACE) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 12 and 36 months ]
- Stent thrombosis [ Time Frame: 12 and 36 months ]
- Device, lesion and procedure success at time of baseline procedure [ Time Frame: 12 and 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328898
|Contact: Pieter R Stella, M.D., PhDemail@example.com|
|Institute of Cardiac Surgery and Interventional Cardiology||Recruiting|
|Contact: Peter Frambach, MD|
|Zuyderland Medical Centre||Recruiting|
|Contact: Mera Stein, MD PhD|
|Utrecht, Netherlands, 3584CM|
|Contact: Pieter R Stella, MD, PhD +31-88-7556167 firstname.lastname@example.org|
|Sub-Investigator: Rik Rozemeijer, MD, MSc|
|Principal Investigator:||Pieter R Stella, M.D., PhD||UMC Utrecht, the Netherlands|