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
  Purpose

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 Intervention Phase
Coronary Occlusions
Device: everolimus-eluting stent
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study

Resource links provided by NLM:


Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • In-stent binary angiographic restenosis rate [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: November 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012869

Locations
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
North Texas Veterans Healthcare System
Investigators
Principal Investigator: Emmanouil S Brilakis, MD, PhD North Texas Veterans Healthcare System
Study Director: Subhash Banerjee, MD North Texas Veterans Healthcare System
  More Information

No publications provided

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
Study First Received: November 12, 2009
Last Updated: October 28, 2013
Health Authority: United States: Federal Government

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
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 23, 2014