ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: Patients must provide written informed consent Patient is at least 18 years old Patients scheduled to undergo PCI of a de novo lesion(s) with reference vessel diameter and lesion length suitable for treatment with at least one study device Patients who agree to comply with the follow up requirements Patients with a life expectancy of > 1 year at time of consent Patients eligible to receive for ≥6 months either dual anti-platelet therapy (DAPT, i.e. 75 mg clopidogrel or another P2Y12 inhibitor per choice of the investigator, and 75-100 mg aspirin) or a combination of an oral anti-coagulant (Vitamin K antagonist or novel anti-coagulant) and a single anti-platelet agent Hemodynamically stable patients Exclusion Criteria: Inability to provide informed consent Currently participating in another clinical trial Planned surgery ≤6 months of PCI unless DAPT or combination anti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgical period Planned use of additional stents other than BioMatrix AlphaTM during the index procedure. Patients with a life expectancy of < 1 year Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated
Sites / Locations
- University Hospitals Birmingham (UHB)
- Royal Blackburn Hospital
- Hull University Teaching Hospitals (HUTH)
- United Lincolnshire Hospitals (ULH)
- The Grange University Hospital, Newport
- Royal Albert Edward Infirmary
Arms of the Study
Arm 1
Experimental
BioMatrix Alpha
All patients will receive the BioMatrix Alpha as per treatment.