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
184 participants
OBSERVATIONAL
2014-08-31
2022-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PDA Coil
Patients age 6 months to 21 years weighing \> 5kg with an angiographically confirmed PDA with a minimum diameter of \< 4 mm.
PDA Coil
The Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter \< 4 mm.
Interventions
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PDA Coil
The Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter \< 4 mm.
Eligibility Criteria
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Inclusion Criteria
* Weight is ≥ 5 kg.
* Age 6 months to 21 years.
Exclusion Criteria
* Known bleeding or coagulation disorder.
* Febrile illness within 7 days of planned procedure.
* Pregnancy.
* Pulmonary hypertension with increased pulmonary vascular resistance (≥ 5 Wood Units).
* Hypersensitivity to contrast medium.
* Known nickel allergy.
6 Months
21 Years
ALL
No
Sponsors
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Bright Research Partners
INDUSTRY
PFM Medical, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel S Levi, MD
Role: PRINCIPAL_INVESTIGATOR
UCLA Pediatric Cardiology
Locations
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Loma Linda University Medical Center
Loma Linda, California, United States
Kaiser Permanente
Los Angeles, California, United States
Children's Hospital of Central California
Madera, California, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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References
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Proposed standards for clinical evaluation of patent ductus arteriosus occlusion devices. Multiorganization Advisory Panel to FDA for Pediatric Cardiovascular Devices. Catheter Cardiovasc Interv. 2000 Nov;51(3):293-6. No abstract available.
Kobayashi D, Salem MM, Forbes TJ, Gordon BM, Soriano BD, Dimas V, Goldstein BH, Owada C, Javois A, Bass J, Jones TK, Berman DP, Gillespie MJ, Moore JW, Levi DS. Results of the combined U.S. multicenter postapproval study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus. Catheter Cardiovasc Interv. 2019 Mar 1;93(4):645-651. doi: 10.1002/ccd.27995. Epub 2018 Dec 3.
Other Identifiers
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TP126
Identifier Type: -
Identifier Source: org_study_id
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