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

Primary Purpose

Coronary Occlusions

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
everolimus-eluting stent
Sponsored by
North Texas Veterans Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Occlusions focused on measuring Coronary chronic total occlusions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dallas VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

everolimus-eluting stent

Arm Description

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)

Outcomes

Primary Outcome Measures

In-stent binary angiographic restenosis rate

Secondary Outcome Measures

In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography
Percent stent strut coverage, as assessed by optical coherence tomography

Full Information

First Posted
November 12, 2009
Last Updated
October 28, 2013
Sponsor
North Texas Veterans Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT01012869
Brief Title
AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study
Acronym
ACE-CTO
Official Title
AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
North Texas Veterans Healthcare System

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Occlusions
Keywords
Coronary chronic total occlusions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
everolimus-eluting stent
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
everolimus-eluting stent
Intervention Description
everolimus-eluting stent (Xience, Abbott Vascular) or Promus (Boston Scientific)
Primary Outcome Measure Information:
Title
In-stent binary angiographic restenosis rate
Time Frame
8 months
Secondary Outcome Measure Information:
Title
In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography
Time Frame
8 months
Title
Percent stent strut coverage, as assessed by optical coherence tomography
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years old 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 Able and willing to return for angiographic follow-up after 8 months and to be followed clinically for 12 months Agree to participate and provide informed consent Exclusion Criteria: Planned non-cardiac surgery within the following 12 months Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy Coexisting conditions that limit life expectancy to less than 12 months Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate) History of an allergic reaction or significant sensitivity to everolimus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanouil S Brilakis, MD, PhD
Organizational Affiliation
North Texas Veterans Healthcare System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Subhash Banerjee, MD
Organizational Affiliation
North Texas Veterans Healthcare System
Official's Role
Study Director
Facility Information:
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26332874
Citation
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.
Results Reference
derived

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

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