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

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-10
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

Exclusion Criteria

• 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)

Banner Samaritan Health Center; 🇺🇸 Phoenix, Arizona, United States

Little Rock VA Medical Center; 🇺🇸 Little Rock, Arkansas, United States

San Diego VAMC and University of California; 🇺🇸 San Diego, California, United States

Torrance Memorial Medical Center; 🇺🇸 Torrance, California, United States

Medical Center of the Rockies; 🇺🇸 Loveland, Colorado, United States

Memorial Hospital; 🇺🇸 Jacksonville, Florida, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital- Emory Heart and Vascular Center; 🇺🇸 Atlanta, Georgia, United States

Wellstar Health System; 🇺🇸 Marietta, Georgia, United States

Northwestern Bluhm Cardiovascular Institute; 🇺🇸 Chicago, Illinois, United States

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