NCT01012869|CompletedPhase 4DMC
AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study
ACE-CTO
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Sponsor study identifier
interventional
100
1 country
1
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 12, 2009
Actual (reported)November 13, 2009
Actual (reported)June 2013
Actual (reported)June 2013
Actual (reported)In-stent binary angiographic restenosis rate
8 months
In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography
8 months
Percent stent strut coverage, as assessed by optical coherence tomography
8 months
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)
everolimus-eluting stent (Xience, Abbott Vascular) or Promus (Boston Scientific)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Device product
everolimus-eluting stent
The registry describes a device or delivery product. Its exact ingredients and actual exposure require separate evidence.
View registry recordDallas VA Medical Center
Dallas, Texas, 75216, United States
Kotsia A, Navara R, Michael TT, Sherbet DP, Roesle M, Christopoulos G, Rangan BV, Haagen D, Garcia S, Maniu C, Pershad A, Abdullah SM, Hastings JL, Kumbhani DJ, Luna M, Addo T, Banerjee S, Brilakis ES. The AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusion (ACE-CTO) Study. J Invasive Cardiol. 2015 Sep;27(9):393-400.
Emmanouil S Brilakis, MD, PhD
North Texas Veterans Healthcare System
Subhash Banerjee, MD
North Texas Veterans Healthcare System
First Submitted
November 12, 2009
First Posted
November 13, 2009
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial
Contact the study team to confirm eligibility.
Study Completion
June 2013
Actual (reported)Last Updated
October 29, 2013
Record last verified: 2012-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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