Trials / Completed
CompletedNCT04137510
Bioflow-DAPT Study
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)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,948 (actual)
- Sponsor
- Biotronik AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study. A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study. Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Percutaneous coronary intervention | It's a non-surgical procedure that uses a catheter to place a stent into a coronary blood vessel in order to open up the vessel. |
Timeline
- Start date
- 2020-02-24
- Primary completion
- 2022-09-20
- Completion
- 2022-09-20
- First posted
- 2019-10-24
- Last updated
- 2024-06-07
Locations
53 sites across 18 countries: Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Hungary, Italy, Latvia, Malaysia, Netherlands, New Zealand, Poland, Singapore, Spain, Switzerland, Thailand
Source: ClinicalTrials.gov record NCT04137510. Inclusion in this directory is not an endorsement.