NIT-OCCLUD PDA Phase II Sentinel Trial

Completed · Not applicable

Conditions studied: Ductus Arteriosus, Patent

In brief

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 compare one year safety and efficacy outcomes with recommended OPCs.

Key facts

Study ID

NCT00828334

Run by

PFM Medical, Inc

People needed

357

Starts

2002-11-01

Expected to finish

2007-10-01

Last updated by the study team

2018-03-23

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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

Where it is running

• Mattel Children's Hospital at UCLA — Los Angeles, California, United States
• Children's Hospital Central California — Madera, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• A.I. Dupont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Hope Children's Hospital — Oak Lawn, Illinois, United States
• Children's Hospital of Illinois — Peoria, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Children's Hospital of Iowa — Iowa City, Iowa, United States
• Children's Hospital of Akron — Akron, Ohio, United States
• Columbus Children's Hospital — Columbus, Ohio, United States
• St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
• Driscoll Children's Hospital — Corpus Christi, Texas, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• Children's Hospital and Regional Medical Center Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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