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OpenTrials
Completed

NCT Number: NCT01012869

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

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.

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Key information

Conditions

Coronary Occlusions Cardiovascular Diseases Coronary Disease Coronary Occlusion Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

everolimus-eluting stent

Device

everolimus-eluting stent (Xience, Abbott Vascular) or Promus (Boston Scientific)

Primary outcomes

  1. In-stent binary angiographic restenosis rate

    Time frame: 8 months

Secondary outcomes

  1. In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography

    Time frame: 8 months

  2. Percent stent strut coverage, as assessed by optical coherence tomography

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

North Texas Veterans Healthcare System

Fed

Registry information

Acronym: ACE-CTO

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 13, 2009
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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