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AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study

This study has been completed.
Sponsor:
Information provided by:
North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01012869
First received: November 12, 2009
Last updated: October 28, 2013
Last verified: April 2012

November 12, 2009
October 28, 2013
November 2009
June 2013   (final data collection date for primary outcome measure)
In-stent binary angiographic restenosis rate [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01012869 on ClinicalTrials.gov Archive Site
  • 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 ]
In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Occlusions
Device: everolimus-eluting stent
everolimus-eluting stent (Xience, Abbott Vascular) or Promus (Boston Scientific)
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)
Intervention: Device: everolimus-eluting stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age > 18 years old
  2. Successful treatment of a native coronary artery CTO (defined as a lesion with 100% angiographic stenosis that is at least 3 months old as estimated by clinical information, sequential angiographic information, or both) using everolimus-eluting stents
  3. Able and willing to return for angiographic follow-up after 8 months and to be followed clinically for 12 months
  4. Agree to participate and provide informed consent

Exclusion Criteria:

  1. Planned non-cardiac surgery within the following 12 months
  2. Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy
  3. Coexisting conditions that limit life expectancy to less than 12 months
  4. Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)
  5. History of an allergic reaction or significant sensitivity to everolimus
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01012869
09-070
Yes
Emmanouil S. Brilakis, MD, PhD, VA North Texas Healthcare System
North Texas Veterans Healthcare System
Not Provided
Principal Investigator: Emmanouil S Brilakis, MD, PhD North Texas Veterans Healthcare System
Study Director: Subhash Banerjee, MD North Texas Veterans Healthcare System
North Texas Veterans Healthcare System
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP