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

NCT05799963 | Active Not Recruiting DMC

• 1 other identifier: 22-EU-03
• Study Type: interventional
• Target: 85
• Locations: 2 countries
• Sites: 9

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with Target Lesion Failure (TLF)

  Primary endpoint is the rate of Target Lesion Failure (TLF) at 9 months defined as cardiovascular death or target vessel myocardial infarction or clinically indicated target lesion revascularization (TLR)

  at 9 months after index procedure

Secondary Outcomes (6)

• Number of participants with Cardiovascular Death (CD)

  at 9 months after index procedure

• Number of participants with Target Vessel Myocardial Infarction

  at 9 months after index procedure

• Number of participants with Clinically indicated Target Lesion Revascularization

  at 9 months after index procedure

• Number of participants with Target Vessel Revascularization

  at 9 months after index procedure

• Number of participants with Stent thrombosis (definite and/or probable)

  at 9 months after index procedure

Study Arms (1)

BioMatrix Alpha

EXPERIMENTAL

All patients will receive the BioMatrix Alpha as per treatment.

Device: BioMatrix Alpha

Interventions

BioMatrix Alpha DEVICE

Patient will be treated with BioMatrix Alpha

BioMatrix Alpha

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosensors Europe SA: lead

Study Sites (9)

Klinikum Bielefeld

Bielefeld, 33604, Germany

Location

Krankenhaus Buchholz

Buchholz, 21244, Germany

Location

Klinikum Lippe GmbH

Detmold, 32758, Germany

Location

University Hospitals Birmingham (UHB)

Birmingham, United Kingdom

Location

Royal Blackburn Hospital

Blackburn, BB2 3HH, United Kingdom

Location

Hull University Teaching Hospitals (HUTH)

Hull, HU3 2JZ, United Kingdom

Location

United Lincolnshire Hospitals (ULH)

Lincoln, United Kingdom

Location

The Grange University Hospital, Newport

Newport, United Kingdom

Location

Royal Albert Edward Infirmary

Wigan, WN1 2NN, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Scot Garg, Professor

  Royal Blackburn Hospital, Haslingden Rd, Blackburn BB2 3HH, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: February 9, 2024
• Primary Completion: July 31, 2025
• Study Completion: March 31, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); GB (6)