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ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD

StatusActive, Not Recruiting
PhaseNot applicable
Started2024-02-09
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 5, 2024 (before its estimated July 31, 2025 completion). Its status may not reflect the trial's current state.
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.

Amendment record

Amended 5 times since 2023-03-23; most recent filed 2024-11-04. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2024-11-04
Amendment Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v5
2024-06-12
Amendment Study Status, Contacts/Locations v4
2024-03-04
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
2023-10-11
Amendment Study Status v2
2023-04-27
Amendment Study Status, Study Description, Study Design, Outcome Measures, Eligibility v1
2023-03-23
Original filing
Trial Details
NCT Number NCT05799963
Lead Sponsor Biosensors Europe SA
Conditions Coronary Artery Disease
Enrollment 85 participants
Start Date 2024-02-09
Primary Completion 2025-07-31 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-05