NL-OMON52323
Completed
Phase 4
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). - BIOFLOW-DAPT study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- BIOTRONIK AG
- Enrollment
- 1
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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