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

October 28, 2013 updated by: North Texas Veterans Healthcare System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-stent binary angiographic restenosis rate
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography
Time Frame: 8 months
8 months
Percent stent strut coverage, as assessed by optical coherence tomography
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 12, 2009

First Submitted That Met QC Criteria

November 12, 2009

First Posted (Estimate)

November 13, 2009

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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