AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study
Chronically total occlusions (CTO) are difficult to treat and have high risk for restenosis. Although everolimus-eluting stents (EES) [(Xience, Abbott Vascular) or Promus (Boston Scientific)] are very promising for the treatment of CTOs due to their low late loss and excellent deliverability, there are currently no published data on EES implantation in CTOs.
The specific aim of this proposal is to examine the 8-month incidence of binary angiographic in-stent restenosis (defined as a stenosis of > 50% of the minimum lumen diameter of the target stent) after implantation of the EES in CTO.
It is the investigators hypothesis that EES-treated CTO lesions will have ≤ 20% 8-month in-stent binary angiographic restenosis rate.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study|
- In-stent binary angiographic restenosis rate [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- Percent stent strut coverage, as assessed by optical coherence tomography [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: everolimus-eluting stent
patients undergoing treatment of a coronary chronic total occlusion (at least 3-months old) using everolimus-eluting stents (Xience, Abbott Vascular) or Promus (Boston Scientific)
Device: everolimus-eluting stent
everolimus-eluting stent (Xience, Abbott Vascular) or Promus (Boston Scientific)
|United States, Texas|
|Dallas VA Medical Center|
|Dallas, Texas, United States, 75216|
|Principal Investigator:||Emmanouil S Brilakis, MD, PhD||North Texas Veterans Healthcare System|
|Study Director:||Subhash Banerjee, MD||North Texas Veterans Healthcare System|