Trials / Unknown
UnknownNCT02594501
Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy
COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 996 (actual)
- Sponsor
- CeloNova BioSciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | COBRA PzF | |
| DEVICE | Drug Eluting Stent |
Timeline
- Start date
- 2016-02-05
- Primary completion
- 2021-05-01
- Completion
- 2021-11-01
- First posted
- 2015-11-03
- Last updated
- 2020-10-26
Locations
48 sites across 8 countries: United States, Belgium, Denmark, France, Germany, Italy, Latvia, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02594501. Inclusion in this directory is not an endorsement.