Trials / Unknown
UnknownNCT01623180
A Randomized Clinical Evaluation of the BioFreedom™ Stent
A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,456 (estimated)
- Sponsor
- Biosensors Europe SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and that its efficacy is superior to a bare metal stent as measured by clinically driven TLR at one year.
Conditions
- Stable Angina
- Ischemic Heart Disease Silent
- ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction
- In-stent Coronary Artery Restenosis
- Bleeding
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Biofreedom™ Drug Coated Stent (DCS) | Biofreedom DCS implantation in high risk bleeding patients followed by 1 month DAPT |
| DEVICE | Gazelle™ Bare Metal Coronary Stent (BMS) | Gazelle BMS implantation in high risk bleeding patients followed by 1 month DAPT |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2015-05-01
- Completion
- 2016-06-01
- First posted
- 2012-06-19
- Last updated
- 2015-08-19
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT01623180. Inclusion in this directory is not an endorsement.