Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The process of re-narrowing of a coronary artery following a revascularization procedure such
as angioplasty, begins at the time of the procedure. Restenosis has long been considered a
major problem for effective long-term interventional success. This often results in repeated
procedures to deal with recurrent stenosis (or restenosis) of the original targeted vessel.
There is a substantial body of literature suggesting that local MYC protein production in the
injured coronary artery is a major stimulus and potential cause of restenosis that appears
after stent placement. This study is based upon the hypothesis that stopping MYC protein
production in the vessel will help reduce restenosis (vessel re-narrowing).
AVI BioPharma Inc., has utilized its proprietary antisense chemistry to design a drug that
interferes with MYC production.
This study will evaluate the safety and potential effectiveness of RESTEN-MP to reduce
in-stent restenosis following balloon angioplasty and stent placement. The post-dose
follow-up period is up to six-months.
RESTEN-MP is administered at the time a stent is successfully placed in a coronary artery,
and again 24 hours later, via slow-push intravenous administration.
Phase:
Phase 2
Details
Lead Sponsor:
Sarepta Therapeutics Sarepta Therapeutics, Inc.
Collaborators:
Baim Institute for Clinical Research Harvard Clinical Research Institute