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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| everolimus-eluting stent | Device | everolimus-eluting stent (Xience, Abbott Vascular) or Promus (Boston Scientific) |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-stent binary angiographic restenosis rate | 8 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanouil S Brilakis, MD, PhD | North Texas Veterans Healthcare System | Principal Investigator |
| Subhash Banerjee, MD | North Texas Veterans Healthcare System | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26332874 | Derived | 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. |
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| ID | Term |
|---|---|
| D054059 | Coronary Occlusion |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D014652 |
| Vascular Diseases |