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

Completed · Phase 4

Conditions studied: Coronary Occlusions

In brief

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.

Key facts

Study ID

NCT01012869

Run by

North Texas Veterans Healthcare System

People needed

100

Starts

2009-11-01

Expected to finish

2013-06-01

Last updated by the study team

2013-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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