Clinical trial NCT02061436: Prospective Global Registry for the Study of Chronic Total Occlusion Intervention
Official title: Multicenter Registry of Chronic Total Occlusion Interventions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: chronic total occlusion, percutaneous coronary intervention
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing CTO PCI at each of the participating centers.

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.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing CTO PCI at each of the participating centers.

Exclusion Criteria:

* None

Primary outcomes:
measure: procedural success of chronic total occlusion PCI
timeFrame: discharge from the hospital after PCI, which usually happens the day after the procedure
Secondary outcomes:
measure: technical success of chronic total occlusion PCI
timeFrame: discharge from the hospital after PCI, which usually happens the day after the procedure
measure: major adverse cardiovascular events
timeFrame: 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.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Samaritan Health Center
state: Arizona
city: Little Rock
country: United States
facility: Little Rock VA Medical Center
state: Arkansas
city: San Diego
country: United States
facility: San Diego VAMC and University of California
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Jacksonville
country: United States
facility: Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital- Emory Heart and Vascular Center
state: Georgia
city: Marietta
country: United States
facility: Wellstar Health System
state: Georgia
city: Chicago
country: United States
facility: Northwestern Bluhm Cardiovascular Institute
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center
state: Indiana
city: New Orleans
country: United States
facility: Tulane University Heart and Vascular Institute
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis VA Healthcare System and University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Mid America Heart Institute
state: Missouri
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Buffalo
country: United States
facility: Trinity Medical WNY
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: New Bern
country: United States
facility: Carolina East Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Ohio Heart & Vascular
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals (UH) Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Kettering
country: United States
facility: Kettering Health Network
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City VA Medical Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Heart Institute at Hillcrest Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart & Vascular Institute
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Presbyterian
state: Pennsylvania
city: York
country: United States
facility: WellSpan Heart & Vascular
state: Pennsylvania
city: Nashville
country: United States
facility: Tristar Centennial Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Dallas
country: United States
facility: VA Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White Research Institute-The Heart Hospital Baylor Plano
state: Texas
city: Plano
country: United States
facility: Baylor Scott and White Research Institute/ The Heart Hospital Baylor Plano
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Waco
country: United States
facility: Providence Health Center
state: Texas
city: Bellingham
country: United States
facility: Peacehealth Cardiology
state: Washington
city: Appleton
country: United States
facility: Appleton Cardiology
state: Wisconsin
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Aswan
country: Egypt
facility: Aswan Heart Centre
city: Athens
country: Greece
facility: Korgialeneio-Benakeio Hellenic Red Cross General Hospital of Athens
state: Attica
city: Athens
country: Greece
facility: Henry Hunant Hospital Center
city: Beirut
country: Lebanon
facility: St. George Hospital University Medical Center
city: Novosibirsk
country: Russian Federation
facility: Meshalkin Novosibirsk Research Institute
state: Novosibirsk Oblast
Study officials:
affiliation: Minneapolis Heart Institute Foundation
name: Emmanouil S Brilakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Tajti P, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel M, Mahmud E, Choi JW, Burke MN, Doing AH, Dattilo P, Toma C, Smith AJC, Uretsky B, Holper E, Potluri S, Wyman RM, Kandzari DE, Garcia S, Krestyaninov O, Khelimskii D, Koutouzis M, Tsiafoutis I, Jaber W, Samady H, Moses JW, Lembo NJ, Parikh M, Kirtane AJ, Ali ZA, Doshi D, Xenogiannis I, Stanberry LI, Rangan BV, Ungi I, Banerjee S, Brilakis ES. In-Hospital Outcomes of Chronic Total Occlusion Percutaneous Coronary Interventions in Patients With Prior Coronary Artery Bypass Graft Surgery. Circ Cardiovasc Interv. 2019 Mar;12(3):e007338. doi: 10.1161/CIRCINTERVENTIONS.118.007338.
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citation: Tajti P, Burke MN, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel M, Mahmud E, Choi JW, Doing AH, Datilo P, Toma C, Smith AJC, Uretsky B, Holper E, Garcia S, Krestyaninov O, Khelimskii D, Koutouzis M, Tsiafoutis I, Moses JW, Lembo NJ, Parikh M, Kirtane AJ, Ali ZA, Doshi D, Jaber W, Samady H, Rangan BV, Xenogiannis I, Ungi I, Banerjee S, Brilakis ES. Prevalence and Outcomes of Percutaneous Coronary Interventions for Ostial Chronic Total Occlusions: Insights From a Multicenter Chronic Total Occlusion Registry. Can J Cardiol. 2018 Oct;34(10):1264-1274. doi: 10.1016/j.cjca.2018.07.472. Epub 2018 Jul 31.
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