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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: BioMatrix Alpha

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.

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bielefeld, Germany, 33604
    • Klinikum Bielefeld
  • Buchholz, Germany, 21244
    • Krankenhaus Buchholz
  • Detmold, Germany, 32758
    • Klinikum Lippe GmbH
• United Kingdom
  • Birmingham, United Kingdom
    • University Hospitals Birmingham (UHB)
  • Blackburn, United Kingdom, BB2 3HH
    • Royal Blackburn Hospital
  • Hull, United Kingdom, HU3 2JZ
    • Hull University Teaching Hospitals (HUTH)
  • Lincoln, United Kingdom
    • United Lincolnshire Hospitals (ULH)
  • Newport, United Kingdom
    • The Grange University Hospital, Newport
  • Wigan, United Kingdom, WN1 2NN
    • Royal Albert Edward Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioMatrix Alpha; All patients will receive the BioMatrix Alpha as per treatment.	Device: BioMatrix Alpha; Patient will be treated with BioMatrix Alpha

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Cardiovascular Death (CD)	Incidence	at 9 months after index procedure
Number of participants with Target Vessel Myocardial Infarction	Target Vessel Myocardial Infarction (TV-MI)	at 9 months after index procedure
Number of participants with Clinically indicated Target Lesion Revascularization	Clinically indicated Target Lesion Revascularization (ci-TLR)	at 9 months after index procedure
Number of participants with Target Vessel Revascularization	Target Vessel Revascularization (TVR)	at 9 months after index procedure
Number of participants with Stent thrombosis (definite and/or probable)	incidence	at 9 months after index procedure
Number of of participants with All-cause mortality	incidence	at 9 months after index procedure

Collaborators and Investigators

• Sponsor: Biosensors Europe SA
• Investigators: Principal Investigator: Scot Garg, Professor, Royal Blackburn Hospital, Haslingden Rd, Blackburn BB2 3HH, UK

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 22-EU-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No