NL-OMON52323CompletedPhase 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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- BIOTRONIK AG
- Enrollment
- 1
Study Overview
Brief Summary
Trial is onging in other countries
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
Investigators
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