Status:
COMPLETED
NIT-OCCLUD PDA Phase II Sentinel Trial
Lead Sponsor:
PFM Medical, Inc
Conditions:
Ductus Arteriosus, Patent
Eligibility:
All Genders
6-21 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the Nit-Occlud -PDA Occlusion System for transcatheter closure of PDA with minimum angiographic diameter less than 4 mm, and to comp...
Detailed Description
The purpose of this clinical investigation is to evaluate whether transcatheter occlusion of PDAs with a minimum vessel diameter of 4 mm or smaller, by means of permanent implantation of the Nit-Occlu...
Eligibility Criteria
Inclusion
- PDA with 4 mm or smaller minimum diameter by color Doppler
- Patent weight \> 5 Kg, Age 6 months to 21 years (Patients older than 21 years may have device implant and be included in a study registry.)
- Previous treatment by surgery or Nit-Occlud device with residual PDA noted at least 6 months after the procedure
- Angiographic minimum PDA diameter (D1) less than 4 mm. (Patients with angiographic diameters larger than 4 mm and smaller or equal to 5 mm may have device implant and be included in a study registry.)
Exclusion
- Associated cardiac anomalies requiring surgery
- Known bleeding or blood clotting disorders
- Ongoing febrile illness
- Pregnancy
- Pulmonary hypertension/increased pulmonary vascular resistance (\>5 Wood Units)
- Known hypersensitivity to contrast medium
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT00828334
Start Date
November 1 2002
End Date
October 1 2007
Last Update
March 23 2018
Active Locations (15)
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1
Mattel Children's Hospital at UCLA
Los Angeles, California, United States, 90095
2
Children's Hospital Central California
Madera, California, United States, 93638
3
Children's Hospital of Orange County
Orange, California, United States, 92868
4
A.I. Dupont Hospital for Children
Wilmington, Delaware, United States, 19899