Phase
Condition
Chest Pain
Vascular Diseases
Coronary Artery Disease
Treatment
BioMatrix Alpha
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 vesseldiameter 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 Kantagonist or novel anti-coagulant) and a single anti-platelet agent
Hemodynamically stable patients
Exclusion
Exclusion Criteria:
Inability to provide informed consent
Currently participating in another clinical trial
Planned surgery ≤6 months of PCI unless DAPT or combinationanti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgicalperiod
Planned use of additional stents other than BioMatrix AlphaTM during the indexprocedure.
Patients with a life expectancy of < 1 year
Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any otherP2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivityto contrast media, which cannot be adequately pre-medicated
Study Design
Study Description
Connect with a study center
Klinikum Bielefeld
Bielefeld, 33604
GermanySite Not Available
Krankenhaus Buchholz
Buchholz, 21244
GermanySite Not Available
Klinikum Lippe GmbH
Detmold, 32758
GermanySite Not Available
University Hospitals Birmingham (UHB)
Birmingham,
United KingdomSite Not Available
Royal Blackburn Hospital
Blackburn, BB2 3HH
United KingdomSite Not Available
Hull University Teaching Hospitals (HUTH)
Hull, HU3 2JZ
United KingdomSite Not Available
United Lincolnshire Hospitals (ULH)
Lincoln,
United KingdomSite Not Available
The Grange University Hospital, Newport
Newport,
United KingdomSite Not Available
Royal Albert Edward Infirmary
Wigan, WN1 2NN
United KingdomSite Not Available
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