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A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Clinical Trial Details

This clinical trial is for men and women diagnosed with ischemic heart disease (myocardial ischemia) who are eligible to be treated with coronary angioplasty (PCI). Eligible patients include persons with angina (stable, unstable, or post-infarct), or silent ischemia. The purpose of the study is to evaluate the safety and effectiveness of the Absorb Bioresorbable Vascular Scaffold (BVS) System made by Abbott Vascular. Unlike traditional metal stents which remain in the body permanently, the Absorb BVS dissolves into the blood vessel, leaving behind a treated vessel that is free of a permanent metallic implant. Study subjects will be randomized to receive either the Absorb BVS or a commercially approved stent, and will be followed up for 5 years.

Key eligibility:

  • Men and women age 18 and older
  • Must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI
  • Must have one or two new lesions in the coronary arteries
  • Detailed eligibility requirements will be reviewed when you contact the study team

Contact

Dolores Reynolds, R.N.
dtr2001@med.cornell.edu
212-746-4617

Primary Investigator

Wong, Sing-Chiu M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1304013875

ClinicalTrials.gov:

NCT01751906

Status:

Open to Enrollment

Sponsor

Drug/Device

Device

Study Type