A Prospective, Randomized, Multi-center Study to Assess the SaFety of the Orsiro Mission Stent compared to the ResoLute Onyx Stent in Subjects at High Risk for Bleeding in combination With 1-month Dual Antiplatelet Therapy (DAPT).
Phase 4
Completed
- Conditions
- Occlusion of bloodvessel(s) in the heart and a high risk for bleedings.10011082
- Registration Number
- NL-OMON52323
- Lead Sponsor
- BIOTRONIK AG
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
Inclusion Criteria
- An acceptable candidate for treatment with a Drug Eluting Stent (DES)
- Considered at high bleeding risk
- >= 18 years old
Exclusion Criteria
- previously experienced stent or scaffold thrombosis in any coronary vessel.
- Revascularization of any target vessel within 9 months prior to the index
procedure or previous PCI of any non-target vessel within 72 hours prior to or
during the index procedure.
- judged by physician as inappropriate for discontinuation from DAPT at 1 month
following index procedure, due to another condition requiring chronic DAPT.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Composite of cardiac death, myocardial infarction (MI) and definite or probable<br /><br>stent thrombosis at 12 months post index procedure in High Bleeding ( risk<br /><br>(HBR) patients treated with either Orsiro Mission stent or with the Resolute<br /><br>Onyx stent in combination with 30-days Dual Antiplatelet Therapy (DAPT)<br /><br>regimen.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Additional endpoints will be measured at the 1-, 6-, and 12-month Follow ups:<br /><br><br /><br>* Rate of definite/probable stent thrombosis (ST) utilizing the Academic<br /><br>Research Consortium-2 (ARC-2) definition.<br /><br>* Rate of major adverse cardiac & cerebrovascular events (MACCE), defined as<br /><br>the composite of all-cause death, MI, and stroke.<br /><br>* Rate of major adverse cardiac events (MACE), defined as the composite of<br /><br>cardiac death, MI, and Target Vessel Revascularization (TVR).<br /><br><br /><br>Please see protocol paragraph 4.8 for the complete list of secondary endpoints.</p><br>