BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02871622
Recruitment Status : Unknown
Verified August 2016 by Biosensors Europe SA. Recruitment status was: Not yet recruiting
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.
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). [ Time Frame: 9 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
"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.
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.
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.