AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study (ACE-CTO)
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|ClinicalTrials.gov Identifier: NCT01012869|
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : October 29, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Occlusions||Device: everolimus-eluting stent||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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)
- In-stent binary angiographic restenosis rate [ Time Frame: 8 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012869
|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|