Trials / Completed
CompletedNCT03344653
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,000 (actual)
- Sponsor
- Medtronic Vascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT |
| DEVICE | Biosensors BioFreedom BA9 Drug Coated Coronary Stent | Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT |
Timeline
- Start date
- 2017-11-02
- Primary completion
- 2018-09-27
- Completion
- 2020-10-09
- First posted
- 2017-11-17
- Last updated
- 2020-12-02
Locations
89 sites across 23 countries: Australia, Austria, Belgium, Bulgaria, France, Hong Kong, Ireland, Italy, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom
Source: ClinicalTrials.gov record NCT03344653. Inclusion in this directory is not an endorsement.