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NIT-OCCLUD PDA Phase II Sentinel Trial

NCT00828334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2018-03-23

No results posted yet for this study

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 compare one year safety and efficacy outcomes with recommended OPCs.

Conditions

  • Ductus Arteriosus, Patent

Interventions

DEVICE

Transcatheter 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.

Sponsors & Collaborators

  • PFM Medical, Inc

    lead INDUSTRY

Principal Investigators

  • John W Moore, MD, MPH · Rady Children's Hospital, San Diego, Department of Pediatrics, UCSD, School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2007-06-30
Completion
2007-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00828334 on ClinicalTrials.gov