Clinical Trial: AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study
Brief Summary:
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.
Detailed Summary:
Sponsor: North Texas Veterans Healthcare System
Current Primary Outcome: In-stent binary angiographic restenosis rate [ Time Frame: 8 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography [ Time Frame: 8 months ]
- Percent stent strut coverage, as assessed by optical coherence tomography [ Time Frame: 8 months ]
Original Secondary Outcome: In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography [ Time Frame: 8 months ]
Information By: North Texas Veterans Healthcare System
Dates:
Date Received: November 12, 2009
Date Started: November 2009
Date Completion:
Last Updated: October 28, 2013
Last Verified: April 2012
