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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,532
Comparison of the Resolute Integrity stent with the Cre8 stent.
Institute of Cardiac Surgery and Interventional Cardiology
Luxembourg, Luxembourg
RECRUITINGZuyderland Medical Centre
Heerlen, Netherlands
RECRUITINGUMC Utrecht
Utrecht, Netherlands
RECRUITINGTarget Lesion Failure (TLF)
Cardiac death, vessel-related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI
Time frame: 12 and 36 months
Net Adverse Clinical Events (NACE)
defined as composite of any death, stroke, myocardial infarction, any unplanned repeated revascularization and bleeding (BARC 3a and above)
Time frame: 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
Time frame: 12 and 36 months
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
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