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Nit-Occlud PDA Post-Approval Study

NCT02100683 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 184

Last updated 2022-10-04

No results posted yet for this study

Summary

The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.

Conditions

  • Patent Ductus Arteriosus (PDA)

Interventions

DEVICE

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

  • Bright Research Partners

    collaborator INDUSTRY

  • PFM Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Daniel S Levi, MD · UCLA Pediatric Cardiology

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2019-11-20
Completion
2022-08-10
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 NCT02100683 on ClinicalTrials.gov