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

Coronary Occlusions Clinical Trial

— ACE-CTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012869
• Other study ID #: 09-070
• Status: Completed
• Phase: Phase 4
• First received: November 12, 2009
• Last updated: October 28, 2013
• Start date: November 2009
• Est. completion date: June 2013

Study information

• Verified date: April 2012
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Occlusion
• Coronary Occlusions

Intervention

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

Locations

Country	Name	City	State
United States	Dallas VA Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent binary angiographic restenosis rate		8 months	No
Secondary	In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography		8 months	No
Secondary	Percent stent strut coverage, as assessed by optical coherence tomography		8 months	Yes