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

NCT ID: NCT01012869

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-06-30

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.

Detailed Description

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Conditions

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Coronary Occlusions

Keywords

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Coronary chronic total occlusions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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everolimus-eluting stent

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)

Group Type EXPERIMENTAL

everolimus-eluting stent

Intervention Type DEVICE

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

Interventions

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everolimus-eluting stent

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Texas Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

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VA North Texas Healthcare System

Principal Investigators

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Emmanouil S Brilakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

North Texas Veterans Healthcare System

Subhash Banerjee, MD

Role: STUDY_DIRECTOR

North Texas Veterans Healthcare System

Locations

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Dallas VA Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26332874 (View on PubMed)

Other Identifiers

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09-070

Identifier Type: -

Identifier Source: org_study_id