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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799963
• Other study ID #: 22-EU-03
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: June 2024
• Source: Biosensors Europe SA
• Contact: Diana Schuette
• Phone: +41(0)218048000
• Email: d.schuette[@]biosensors.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: March 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• BioMatrix Alpha
Patient will be treated with BioMatrix Alpha

Locations

Country	Name	City	State
Germany	Klinikum Bielefeld	Bielefeld
Germany	Krankenhaus Buchholz	Buchholz
Germany	Klinikum Lippe GmbH	Detmold
United Kingdom	University Hospitals Birmingham (UHB)	Birmingham
United Kingdom	Royal Blackburn Hospital	Blackburn
United Kingdom	Hull University Teaching Hospitals (HUTH)	Hull
United Kingdom	United Lincolnshire Hospitals (ULH)	Lincoln
United Kingdom	The Grange University Hospital, Newport	Newport
United Kingdom	Royal Albert Edward Infirmary	Wigan

Sponsors (1)

Lead Sponsor	Collaborator
Biosensors Europe SA

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

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