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

• Sponsor: Biosensors Europe SA (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05799963
• Collaborator: (none)
• Enrollment: 85
• Locations: 6
• Arm: 1
• Anticipated Duration (Months): 31.5
• Patients Per Site: 14.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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 1 year. The "BMX Alpha Registry" study will serve as reference and historic comparator.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: BioMatrix Alpha	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 85 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, multi-center, open-label single-arm studyProspective, multi-center, open-label single-arm study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Aug 14, 2023
• Anticipated Primary Completion Date: Jul 31, 2025
• Anticipated Study Completion Date: Mar 31, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Target Lesion Failure (TLF) [at 12 months after index procedure]

   Primary endpoint is the rate of Target Lesion Failure (TLF) at 12 months defined as cardiovascular death or target vessel myocardial infarction or clinically indicated target lesion revascularization (TLR)

Secondary Outcome Measures

1. Cardiovascular Death (CD) [at 12 months after index procedure]

   Incidence

2. Target Vessel Myocardial Infarction [at 12 months after index procedure]

   Target Vessel Myocardial Infarction (TV-MI)

3. Clinically indicated Target Lesion Revascularization [at 12 months after index procedure]

   Clinically indicated Target Lesion Revascularization (ci-TLR)

4. Target Vessel Revascularization [at 12 months after index procedure]

   Target Vessel Revascularization (TVR)

5. Stent thrombosis (definite and/or probable) [at 12 months after index procedure]

   incidence

6. All-cause mortality [at 12 months after index procedure]

   incidence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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

2. Patients who agree to comply with the follow up requirements

3. Patients with a life expectancy of > 1 year at time of consent

4. Patients eligible to receive dual anti platelet therapy (DAPT) for 6 months

5. Hemodynamically stable patients

Exclusion Criteria:

1. Inability to provide informed consent

2. Currently participating in another clinical trial

3. Planned surgery within 6 months of PCI unless dual antiplatelet therapy (DAPT)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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Birmingham (UHB)	Birmingham		United Kingdom
2	Royal Blackburn Hospital	Blackburn		United Kingdom	BB2 3HH
3	Hull University Teaching Hospitals (HUTH)	Hull		United Kingdom	HU3 2JZ
4	United Lincolnshire Hospitals (ULH)	Lincoln		United Kingdom
5	The Grange University Hospital, Newport	Newport		United Kingdom
6	Royal Albert Edward Infirmary	Wigan		United Kingdom	WN1 2NN

Sponsors and Collaborators

• Biosensors Europe SA

Investigators

• Principal Investigator: Scot Garg, Professor, Royal Blackburn Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosensors Europe SA
• ClinicalTrials.gov Identifier: NCT05799963
• Other Study ID Numbers: 22-EU-03
• First Posted: Apr 5, 2023
• Last Update Posted: Apr 5, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of Apr 5, 2023