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

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ClinicalTrials.gov Identifier: NCT02061436
Recruitment Status : Recruiting
First Posted : February 12, 2014
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Coronary Artery Disease

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Multicenter Registry of Chronic Total Occlusion Interventions
Study Start Date : January 2012
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. procedural success of chronic total occlusion PCI [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing CTO PCI at each of the participating centers.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061436


Contacts
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Contact: Emmanouil S Brilakis, MD, PhD (214) 857-1547 ext 71547 esbrilakis@gmail.com

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Sponsors and Collaborators
Minneapolis Heart Institute Foundation
Investigators
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Principal Investigator: Emmanouil S Brilakis, MD, PhD Minneapolis Heart Institute Foundation

Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT02061436     History of Changes
Other Study ID Numbers: #11-099
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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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:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases