Trials / Active Not Recruiting
Active Not RecruitingNCT05799963
ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD
A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of Additional Sizes of the BioMatrix AlphaTM (Cobalt Chromium Biolimus A9TM Drug-eluting Stent) - ALPHA LONG Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- Sponsor
- Biosensors Europe SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multi-center, open-label single-arm study designed to enroll 85 patients in up to 15 centers in up to 3 European countries. All patients will be followed up for 9 months. The "BMX Alpha Registry" study will serve as reference and historic comparator.
Detailed description
The objective of this study is to evaluate if PCI performed using the additional sizes of the BioMatrix AlphaTM stent results in similar safety and efficacy outcomes as the currently approved (CE marked) sizes of BioMatrix Alpha.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BioMatrix Alpha | Patient will be treated with BioMatrix Alpha |
Timeline
- Start date
- 2024-02-09
- Primary completion
- 2025-07-31
- Completion
- 2026-03-31
- First posted
- 2023-04-05
- Last updated
- 2024-11-05
Locations
9 sites across 2 countries: Germany, United Kingdom
Source: ClinicalTrials.gov record NCT05799963. Inclusion in this directory is not an endorsement.