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

NCT01012869 | Completed Phase 4 DMC

• 1 other identifier: 09-070
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Occlusions

Keywords

Coronary chronic total occlusions

Outcome Measures

Primary Outcomes (1)

• In-stent binary angiographic restenosis rate

  8 months

Secondary Outcomes (2)

• In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography

  8 months

• Percent stent strut coverage, as assessed by optical coherence tomography

  8 months

Study Arms (1)

everolimus-eluting stent

EXPERIMENTAL

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

Interventions

everolimus-eluting stent DEVICE

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

everolimus-eluting stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Related Publications (1)

• 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.

  PMID: 26332874 DERIVED

MeSH Terms

Conditions

Coronary Occlusion

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Emmanouil S Brilakis, MD, PhD

  North Texas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

• Subhash Banerjee, MD

  North Texas Veterans Healthcare System

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 13, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 29, 2013

Record last verified: 2012-04

Locations

US (1)