CompletedNot Applicable

e-BioMatrix Canada Registry

Canada535 participantsStarted 2013-05

Plain-language summary

Prospective, multi-center registry to be conducted at 6 Canadian interventional cardiology centers. The e-BioMatrix data will be compared with a historical control group, the Cypher arm of the Biosensors Leaders study consisting of 313 patients. All patients will be followed for up to 2 years.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years
✓. Presence of coronary artery stenosis in one or two native coronary arteries from 2.25 to 4.0 mm in diameter that can be each covered with one BioMatrix FlexTM stent
✓. Up to two lesions in two separate vessels to be treated

Exclusion criteria

✕. Inability to provide informed consent;
✕. Life expectancy less than 2 years;
✕. Staged procedure planned within index procedure hospitalization;
✕. ST elevation myocardial infarction;
✕. Angiographic evidence of thrombus;
✕. EF \< 20%;
✕. Coronary artery bypass graft-lesion incl SVG;
✕. Chronic total occlusion of the target lesion;

What they're measuring

Registry device-related MACE

Timeframe: 12 months

Trial details

NCT IDNCT01915628

SponsorBiosensors Europe SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Device Related MACE and Bleeding trials