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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Occlusions

Intervention / Treatment
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* Device: everolimus-eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: everolimus-eluting stent<br>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<br>* everolimus-eluting stent (Xience, Abbott Vascular) or Promus (Boston Scientific)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary chronic total occlusions