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Trial record 38 of 77 for:    "Heart Disease" | "Cobalt"

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
First Posted : August 18, 2016
Last Update Posted : August 18, 2016
Sponsor:
Collaborator:
European Cardiovascular Research Center
Information provided by (Responsible Party):
Biosensors Europe SA

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Stable Angina Ischemia Acute Coronary Syndrome NSTEMI STEMI Device: BioMatrix AlphaTM

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: A Post-market Registry of the BioMatrix Alpha TM (Cobalt Chromium Biolimus A9TM (BA9TM) Drug-eluting Stent)
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Chromium


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


Primary Outcome Measures :
  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). [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871622


Contacts
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Contact: Diana Schuette +447 970 942 022 d.schuette-consultant@biosensors.com
Contact: Abderrahim Kadri +33 176 739 210 akadri@cerc-europe.org

Locations
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United Kingdom
Craigavon Cardiac Center
Craigavon, United Kingdom
Sponsors and Collaborators
Biosensors Europe SA
European Cardiovascular Research Center
Investigators
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Principal Investigator: Ian BA Menown, Dr Craigavon Cardiac Centre

Additional Information:

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Responsible Party: Biosensors Europe SA
ClinicalTrials.gov Identifier: NCT02871622     History of Changes
Other Study ID Numbers: 16EU01
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not planned
Additional relevant MeSH terms:
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Heart Diseases
Coronary Artery Disease
Acute Coronary Syndrome
Angina, Stable
Ischemia
Coronary Disease
Myocardial Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Chromium
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs