ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patien... | NCT05799963

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

NCT05799963

Sponsor

Biosensors Europe SA

Status

Active, not recruiting

Last Update Posted

Nov 5, 2024Actual

Enrollment

85Estimated

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

BioMatrix Alpha

Countries

Germany
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2024Actual

Primary Completion Date

Jul 31, 2025Estimated

Completion Date

Mar 31, 2026Estimated

First Submitted Date

Mar 23, 2023

First Submission Date that Met QC Criteria

Mar 23, 2023

First Posted Date

Apr 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2024

Last Update Posted Date

Nov 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BioMatrix Alpha	Experimental	All patients will receive the BioMatrix Alpha as per treatment.	Device: BioMatrix Alpha

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BioMatrix Alpha	Device	Patient will be treated with BioMatrix Alpha	BioMatrix Alpha

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Scot Garg, Professor	Royal Blackburn Hospital, Haslingden Rd, Blackburn BB2 3HH, UK	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Bielefeld		Bielefeld		33604	Germany
Krankenhaus Buchholz

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003324	Coronary Artery Disease

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Intervention 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.