Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2022-07-18
2023-11-21
Brief Summary
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Detailed Description
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This clinical investigation is being conducted under Exception from Informed Consent (EFIC) regulations because there is no reasonable way to identify patients likely to become eligible for the investigation, and a coronary perforation can be a life-threatening emergency that needs to be immediately controlled without enough time for the patient or their legally authorized representative to give consent. Patients will be notified of their enrollment as soon as feasible. For more information on the exception from informed consent, please use the contact information be.ow.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental Arm
Adult subjects who experience a perforation of a coronary vessel during percutaneous coronary intervention (PCI) and require management of hemorrhage until a definitive treatment is determined.
Experimental
Prolonged balloon inflation for hemorrhage management due to coronary artery perforation.
Interventions
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Experimental
Prolonged balloon inflation for hemorrhage management due to coronary artery perforation.
Eligibility Criteria
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Inclusion Criteria
* Subject has fluoroscopically confirmed vessel perforation (classified as any type) requiring management of hemorrhage until a definitive treatment is determined
* Female subjects of childbearing potential must have a negative pregnancy test per standard of care for PCI
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Vascular Solutions LLC
INDUSTRY
Responsible Party
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Principal Investigators
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David E Kandzari, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Heart Institute
Locations
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Piedmont Heart Institute
Atlanta, Georgia, United States
Emory Heart & Vascular Center
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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ST3031
Identifier Type: -
Identifier Source: org_study_id