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

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
BioMatrix Alpha
Sponsored by
Biosensors Europe SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • University Hospitals Birmingham (UHB)
  • Royal Blackburn Hospital
  • Hull University Teaching Hospitals (HUTH)
  • United Lincolnshire Hospitals (ULH)
  • The Grange University Hospital, Newport
  • Royal Albert Edward Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BioMatrix Alpha

Arm Description

All patients will receive the BioMatrix Alpha as per treatment.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of participants with Cardiovascular Death (CD)
Incidence
Number of participants with Target Vessel Myocardial Infarction
Target Vessel Myocardial Infarction (TV-MI)
Number of participants with Clinically indicated Target Lesion Revascularization
Clinically indicated Target Lesion Revascularization (ci-TLR)
Number of participants with Target Vessel Revascularization
Target Vessel Revascularization (TVR)
Number of participants with Stent thrombosis (definite and/or probable)
incidence
Number of of participants with All-cause mortality
incidence

Full Information

First Posted
March 23, 2023
Last Updated
October 11, 2023
Sponsor
Biosensors Europe SA
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1. Study Identification

Unique Protocol Identification Number
NCT05799963
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 14, 2023 (Anticipated)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosensors Europe SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BioMatrix Alpha
Arm Type
Experimental
Arm Description
All patients will receive the BioMatrix Alpha as per treatment.
Intervention Type
Device
Intervention Name(s)
BioMatrix Alpha
Intervention Description
Patient will be treated with BioMatrix Alpha
Primary Outcome Measure Information:
Title
Number of participants with Target Lesion Failure (TLF)
Description
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)
Time Frame
at 9 months after index procedure
Secondary Outcome Measure Information:
Title
Number of participants with Cardiovascular Death (CD)
Description
Incidence
Time Frame
at 9 months after index procedure
Title
Number of participants with Target Vessel Myocardial Infarction
Description
Target Vessel Myocardial Infarction (TV-MI)
Time Frame
at 9 months after index procedure
Title
Number of participants with Clinically indicated Target Lesion Revascularization
Description
Clinically indicated Target Lesion Revascularization (ci-TLR)
Time Frame
at 9 months after index procedure
Title
Number of participants with Target Vessel Revascularization
Description
Target Vessel Revascularization (TVR)
Time Frame
at 9 months after index procedure
Title
Number of participants with Stent thrombosis (definite and/or probable)
Description
incidence
Time Frame
at 9 months after index procedure
Title
Number of of participants with All-cause mortality
Description
incidence
Time Frame
at 9 months after index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Schuette
Phone
+41(0)218048000
Email
d.schuette@biosensors.com
First Name & Middle Initial & Last Name or Official Title & Degree
Keith Oldroyd, MD
Phone
+41(0)218048000
Email
k.oldroyd@biosensors.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scot Garg, Professor
Organizational Affiliation
Royal Blackburn Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Birmingham (UHB)
City
Birmingham
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohail Khan
Facility Name
Royal Blackburn Hospital
City
Blackburn
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scot Garg, Professor
Facility Name
Hull University Teaching Hospitals (HUTH)
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj Chelliah
Phone
01482 875875
Facility Name
United Lincolnshire Hospitals (ULH)
City
Lincoln
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelvin Lee
Facility Name
The Grange University Hospital, Newport
City
Newport
Country
United Kingdom
Facility Name
Royal Albert Edward Infirmary
City
Wigan
ZIP/Postal Code
WN1 2NN
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abhishek Kumar
Email
abhishek.kumar@wwl.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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