OHSU

IRB #

IRB00008988

Title

The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent (BIOHELIX-I)

Principal Investigator

Yen Tibayan

Study Purpose

The purpose of this study is to test the safety and effectiveness of the study device that may be used during a scheduled angioplasty. Angioplasty is a procedure which helps increase blood flow to the heart.

Medical Condition(s)

Coronary artery disease (CAD) which leads to a hardening and narrowing of the arteries in the heart.

Eligibility Criteria

Includes but not limited to:
-Men and women aged 18+
-Diagnosed CAD
-Scheduled for angioplasty procedure as part of standard care

Age Range

18 - 95

Healthy Volunteers Needed

No

Duration of Participation

About 3 years

Minors Included

No

Contact

Susan Dean, RN, BSN, MPH, CCRC
Phone: (503) 494-6072

Sponsor

Biotronik, Inc.

Recruitment End

12/31/2014

Compensation Provided

No


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