Trials / Unknown
UnknownNCT02871622
BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM
A Post-market Registry of the BioMatrix Alpha TM (Cobalt Chromium Biolimus A9TM (BA9TM) Drug-eluting Stent)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (estimated)
- Sponsor
- Biosensors Europe SA · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35 International centers. All patients will receive a BioMatrix AlphaTM stent as per clinical practice and will be followed for 2 years for data collection. Major adverse cardiac events (MACE) results at 9 months will be compared to the results obtained from the BioMatrix FlexTM arm of the LEADERS trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BioMatrix AlphaTM | Cobalt Chromium BA9 TM drug-eluting stent |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2017-12-01
- Completion
- 2019-10-01
- First posted
- 2016-08-18
- Last updated
- 2016-08-18
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02871622. Inclusion in this directory is not an endorsement.