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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01012869

Acronym

ACE-CTO

Enrollment

100

Registered

2009-11-13

Start date

2009-11-30

Completion date

2013-06-30

Last updated

2013-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Occlusions

Keywords

Coronary chronic total occlusions

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.

Interventions

DEVICEeverolimus-eluting stent

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
In-stent binary angiographic restenosis rate	8 months

Secondary

Measure	Time frame
In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography	8 months
Percent stent strut coverage, as assessed by optical coherence tomography	8 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026