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The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO

NCT04029233 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 582

Last updated 2024-09-19

No results posted yet for this study

Summary

Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

Conditions

  • Stroke
  • PFO - Patent Foramen Ovale

Interventions

DEVICE

Occlutech PFO Occluder

The Occlutech PFO Occluder is a medical device for transcatheter closure of PFO.

Sponsors & Collaborators

  • Occlutech International AB

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-03
Primary Completion
2024-04-16
Completion
2024-04-16

Countries

  • Canada
  • France
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT04029233 on ClinicalTrials.gov