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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
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Coronary Occlusions Device: everolimus-eluting stent Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study
Study Start Date : November 2009
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :
  1. In-stent binary angiographic restenosis rate [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography [ Time Frame: 8 months ]
  2. Percent stent strut coverage, as assessed by optical coherence tomography [ Time Frame: 8 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
North Texas Veterans Healthcare System
Principal Investigator: Emmanouil S Brilakis, MD, PhD North Texas Veterans Healthcare System
Study Director: Subhash Banerjee, MD North Texas Veterans Healthcare System
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emmanouil S. Brilakis, MD, PhD, VA North Texas Healthcare System
ClinicalTrials.gov Identifier: NCT01012869     History of Changes
Other Study ID Numbers: 09-070
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: April 2012

Keywords provided by North Texas Veterans Healthcare System:
Coronary chronic total occlusions

Additional relevant MeSH terms:
Coronary Occlusion
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents