Clincosm LogoSign in Get a demo

PROGRESS-CTO: Prospective Global Registry for the Study of Chronic Total Occlusion Intervention

Sponsor
Minneapolis Heart Institute Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT02061436
Collaborator
(none)
2,000
Enrollment
48
Locations
144
Duration (Months)
41.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multicenter Registry of Chronic Total Occlusion Interventions
    Study Start Date :
    Jan 1, 2012
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing CTO PCI at each of the participating centers.
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner Samaritan Health Center Phoenix Arizona United States 85006
    2 Little Rock VA Medical Center Little Rock Arkansas United States 72205
    3 San Diego VAMC and University of California San Diego California United States 92161
    4 Torrance Memorial Medical Center Torrance California United States 90505
    5 Medical Center of the Rockies Loveland Colorado United States 80538
    6 Memorial Hospital Jacksonville Florida United States 32216
    7 Piedmont Heart Institute Atlanta Georgia United States 30309
    8 Emory University Hospital- Emory Heart and Vascular Center Atlanta Georgia United States 30322
    9 Wellstar Health System Marietta Georgia United States 30060
    10 Northwestern Bluhm Cardiovascular Institute Chicago Illinois United States 60611
    11 St. Vincent Heart Center Indianapolis Indiana United States 46260
    12 Tulane University Heart and Vascular Institute New Orleans Louisiana United States 70112
    13 Massachusetts General Hospital Boston Massachusetts United States 02114
    14 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    15 Henry Ford Medical Center Detroit Michigan United States 48202
    16 Minneapolis Heart Institute Minneapolis Minnesota United States 55407
    17 Minneapolis VA Healthcare System and University of Minnesota Minneapolis Minnesota United States 55417
    18 Mid America Heart Institute Kansas City Missouri United States 64131
    19 Maimonides Medical Center Brooklyn New York United States 11219
    20 Trinity Medical WNY Buffalo New York United States 14221
    21 Columbia University New York New York United States 10032
    22 Carolina East Medical Center New Bern North Carolina United States 28560
    23 The Christ Hospital Ohio Heart & Vascular Cincinnati Ohio United States 45219
    24 University Hospitals (UH) Case Western Reserve University Cleveland Ohio United States 44106
    25 Cleveland Clinic Cleveland Ohio United States 44195
    26 Kettering Health Network Kettering Ohio United States 45429
    27 Oklahoma City VA Medical Center Oklahoma City Oklahoma United States 73117
    28 Oklahoma Heart Institute at Hillcrest Medical Center Tulsa Oklahoma United States 74104
    29 Providence Heart & Vascular Institute Portland Oregon United States 97225
    30 University of Pittsburgh Medical Center Presbyterian Pittsburgh Pennsylvania United States 15213
    31 WellSpan Heart & Vascular York Pennsylvania United States 17405
    32 Tristar Centennial Medical Center Nashville Tennessee United States 37203
    33 University of Texas Southwestern Medical Center Dallas Texas United States 75216
    34 VA Dallas Medical Center Dallas Texas United States 75216
    35 Baylor Heart and Vascular Hospital Dallas Texas United States 75226
    36 Houston Methodist Hospital Houston Texas United States 77030
    37 Baylor Scott & White Research Institute-The Heart Hospital Baylor Plano Plano Texas United States 75093
    38 Baylor Scott and White Research Institute/ The Heart Hospital Baylor Plano Plano Texas United States 75093
    39 The Heart Hospital Baylor Plano Plano Texas United States 75093
    40 Providence Health Center Waco Texas United States 76712
    41 Peacehealth Cardiology Bellingham Washington United States 98225
    42 Appleton Cardiology Appleton Wisconsin United States 54911
    43 St. Boniface General Hospital Winnipeg Manitoba Canada R3E 0W3
    44 Aswan Heart Centre Aswan Egypt
    45 Korgialeneio-Benakeio Hellenic Red Cross General Hospital of Athens Athens Attica Greece 11526
    46 Henry Hunant Hospital Center Athens Greece
    47 St. George Hospital University Medical Center Beirut Lebanon
    48 Meshalkin Novosibirsk Research Institute Novosibirsk Novosibirsk Oblast Russian Federation 630055

    Sponsors and Collaborators

    • Minneapolis Heart Institute Foundation

    Investigators

    • Principal Investigator: Emmanouil S Brilakis, MD, PhD, Minneapolis Heart Institute Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Minneapolis Heart Institute Foundation
    ClinicalTrials.gov Identifier:
    NCT02061436
    Other Study ID Numbers:
    • #11-099
    First Posted:
    Feb 12, 2014
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Minneapolis Heart Institute Foundation
    chronic total occlusion, percutaneous coronary intervention
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Mar 10, 2022