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

Veterans Affairs (VA) North Texas Health Care System

Status and phase: Completed; Phase 4

Conditions: Coronary Occlusions

Treatments: Device: everolimus-eluting stent

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01012869

09-070

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

everolimus-eluting stent

Experimental group

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)

Treatment:

Device: everolimus-eluting stent