Prospective Global Registry for the Study of Chronic Total Occlusion Intervention
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT02061436
- Lead Sponsor
- Minneapolis Heart Institute Foundation
- Brief Summary
Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly being performed in patients with advanced coronary artery disease, but there is limited information on the techniques utilized and the procedural outcomes. The goal of this multicenter, investigator initiated registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing CTO PCI among various participating centers. The information collected will be used to determine the frequency of CTO PCI performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and during follow-up) outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
- Patients undergoing CTO PCI at each of the participating centers.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method procedural success of chronic total occlusion PCI discharge from the hospital after PCI, which usually happens the day after the procedure Procedural success is defined as achievement of technical success with no in-hospital major adverse cardiac events (MACE). In-hospital MACE includes any of the following adverse events prior to hospital discharge: death from any cause, Q-wave myocardial infarction, urgent repeat target vessel revascularization with PCI or coronary bypass surgery, tamponade requiring pericardiocentesis or surgery, or stroke.
- Secondary Outcome Measures
Name Time Method technical success of chronic total occlusion PCI discharge from the hospital after PCI, which usually happens the day after the procedure Technical success of CTO PCI was defined as successful CTO revascularization with achievement of \<30% residual diameter stenosis within the treated segment and restoration of TIMI grade 3 antegrade flow.
major adverse cardiovascular events discharge from the hospital after PCI (which usually happens the day after the procedure) and during clinically-indicated follow-up. There are no pre-specified follow-up time periods - patients are assessed if and when they come to receive clinical care. In-hospital major adverse cardiovascular events (MACE) include any of the following adverse events prior to hospital discharge: death from any cause, Q-wave myocardial infarction, urgent repeat target vessel revascularization with PCI or coronary bypass surgery, tamponade requiring pericardiocentesis or surgery, or stroke.
MACE during clinical follow-up include death, myocardial infarction, target lesion and target vessel revascularization.
Trial Locations
- Locations (48)
Emory University Hospital- Emory Heart and Vascular Center
🇺🇸Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University Hospitals (UH) Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Banner Samaritan Health Center
🇺🇸Phoenix, Arizona, United States
St. Vincent Heart Center
🇺🇸Indianapolis, Indiana, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Northwestern Bluhm Cardiovascular Institute
🇺🇸Chicago, Illinois, United States
San Diego VAMC and University of California
🇺🇸San Diego, California, United States
Minneapolis VA Healthcare System and University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Tulane University Heart and Vascular Institute
🇺🇸New Orleans, Louisiana, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
Little Rock VA Medical Center
🇺🇸Little Rock, Arkansas, United States
Memorial Hospital
🇺🇸Jacksonville, Florida, United States
Trinity Medical WNY
🇺🇸Buffalo, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Columbia University
🇺🇸New York, New York, United States
The Christ Hospital Ohio Heart & Vascular
🇺🇸Cincinnati, Ohio, United States
Providence Heart & Vascular Institute
🇺🇸Portland, Oregon, United States
VA Dallas Medical Center
🇺🇸Dallas, Texas, United States
Korgialeneio-Benakeio Hellenic Red Cross General Hospital of Athens
🇬🇷Athens, Attica, Greece
Henry Hunant Hospital Center
🇬🇷Athens, Greece
Providence Health Center
🇺🇸Waco, Texas, United States
St. George Hospital University Medical Center
🇱🇧Beirut, Lebanon
Meshalkin Novosibirsk Research Institute
🇷🇺Novosibirsk, Novosibirsk Oblast, Russian Federation
Baylor Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Peacehealth Cardiology
🇺🇸Bellingham, Washington, United States
Appleton Cardiology
🇺🇸Appleton, Wisconsin, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Aswan Heart Centre
🇪🇬Aswan, Egypt
Oklahoma Heart Institute at Hillcrest Medical Center
🇺🇸Tulsa, Oklahoma, United States
Oklahoma City VA Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Henry Ford Medical Center
🇺🇸Detroit, Michigan, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Carolina East Medical Center
🇺🇸New Bern, North Carolina, United States
University of Pittsburgh Medical Center Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor Scott and White Research Institute/ The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Tristar Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
WellSpan Heart & Vascular
🇺🇸York, Pennsylvania, United States
Wellstar Health System
🇺🇸Marietta, Georgia, United States
Mid America Heart Institute
🇺🇸Kansas City, Missouri, United States
Kettering Health Network
🇺🇸Kettering, Ohio, United States
Baylor Scott & White Research Institute-The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States