Clinical trial NCT05799963: ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
First posted: 2023-04-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, open-label single-arm study. 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patients must provide written informed consent
2. Patient is at least 18 years old
3. 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
4. Patients who agree to comply with the follow up requirements
5. Patients with a life expectancy of \> 1 year at time of consent
6. 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
7. Hemodynamically stable patients

Exclusion Criteria:

1. Inability to provide informed consent
2. Currently participating in another clinical trial
3. Planned surgery ≤6 months of PCI unless DAPT or combination anti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgical period
4. Planned use of additional stents other than BioMatrix AlphaTM during the index procedure.
5. Patients with a life expectancy of \< 1 year
6. 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

Primary outcomes:
measure: Number of participants with Target Lesion Failure (TLF)
timeFrame: at 9 months after index procedure
Secondary outcomes:
measure: Number of participants with Cardiovascular Death (CD)
timeFrame: at 9 months after index procedure
measure: Number of participants with Target Vessel Myocardial Infarction
timeFrame: at 9 months after index procedure
measure: Number of participants with Clinically indicated Target Lesion Revascularization
timeFrame: at 9 months after index procedure
measure: Number of participants with Target Vessel Revascularization
timeFrame: at 9 months after index procedure
measure: Number of participants with Stent thrombosis (definite and/or probable)
timeFrame: at 9 months after index procedure
measure: Number of of participants with All-cause mortality
timeFrame: at 9 months after index procedure
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld
city: Buchholz
country: Germany
facility: Krankenhaus Buchholz
city: Detmold
country: Germany
facility: Klinikum Lippe GmbH
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham (UHB)
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals (HUTH)
city: Lincoln
country: United Kingdom
facility: United Lincolnshire Hospitals (ULH)
city: Newport
country: United Kingdom
facility: The Grange University Hospital, Newport
city: Wigan
country: United Kingdom
facility: Royal Albert Edward Infirmary
Study officials:
affiliation: Royal Blackburn Hospital, Haslingden Rd, Blackburn BB2 3HH, UK
name: Scot Garg, Professor
role: PRINCIPAL_INVESTIGATOR
References: