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

NCT01012869 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-10-29

No results posted yet for this study

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

Interventions

DEVICE

everolimus-eluting stent

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

Sponsors & Collaborators

  • North Texas Veterans Healthcare System

    lead FED

Principal Investigators

  • Emmanouil S Brilakis, MD, PhD · North Texas Veterans Healthcare System

  • Subhash Banerjee, MD · North Texas Veterans Healthcare System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01012869 on ClinicalTrials.gov