BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM

Coronary Artery Disease Clinical Trial

Official title:

A Post-market Registry of the BioMatrix Alpha TM (Cobalt Chromium Biolimus A9TM (BA9TM) Drug-eluting Stent)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02871622
• Other study ID #: 16EU01
• Status: Not yet recruiting
• Phase: N/A
• First received: August 15, 2016
• Last updated: August 15, 2016
• Start date: September 2016
• Est. completion date: October 2019

Study information

• Verified date: August 2016
• Source: Biosensors Europe SA
• Contact: Diana Schuette
• Phone: +447 970 942 022
• Email: d.schuette-consultant[@]biosensors.com
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35 International centers. All patients will receive a BioMatrix AlphaTM stent as per clinical practice and will be followed for 2 years for data collection. Major adverse cardiac events (MACE) results at 9 months will be compared to the results obtained from the BioMatrix FlexTM arm of the LEADERS trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: October 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients treated with the BioMatrix AlphaTM stent per clinical indication and physician's choice;

• 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 dual anti platelet therapy (DAPT) according to guidelines;

• Hemodynamically stable patients.

Exclusion Criteria:

• Inability to provide informed consent;

• Currently participating in another trial before reaching primary endpoint;

• Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the perisurgical period;

• Patient has received an additional stent different from a BioMatrix AlphaTM stent during the index procedure.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia
• NSTEMI
• Stable Angina
• STEMI

Intervention

Device:
• BioMatrix AlphaTM
Cobalt Chromium BA9 TM drug-eluting stent

Locations

Country	Name	City	State
United Kingdom	Craigavon Cardiac Center	Craigavon

Sponsors (2)

Lead Sponsor	Collaborator
Biosensors Europe SA	European Cardiovascular Research Center

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or clinically driven target vessel revascularization (TVR).		9 months	Yes