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

NCT02871622 | Unknown DMC

• 1 other identifier: 16EU01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Stable Angina; Ischemia; Acute Coronary Syndrome; NSTEMI; STEMI

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

BioMatrix AlphaTM DEVICE

Cobalt Chromium BA9 TM drug-eluting stent

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

"Real world, all comers" patient population: Patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosensors Europe SA: lead
• European Cardiovascular Research Center: collaborator

Study Sites (1)

Craigavon Cardiac Center

Craigavon, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Ischemia; Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Myocardial Infarction; Infarction; Necrosis

Study Officials

• Ian BA Menown, Dr

  Craigavon Cardiac Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Schuette

CONTACT

+447 970 942 022; d.schuette-consultant@biosensors.com

Abderrahim Kadri

CONTACT

+33 176 739 210; akadri@cerc-europe.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 18, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: October 1, 2019
• Last Updated: August 18, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)