PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness

Not Applicable

Suspended

• Conditions: PFO; Stroke; Transient Ischemic Attack; Migraine; Decompression Illness

• Registration Number: NCT00529945
• Lead Sponsor: Cierra

Brief Summary

The primary object of this study is to demonstrate the continued safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-12
• Study First Submitted QC: 2007-09-13
• Study First Posted: 2007-09-14
• Status Verified: 2007-12
• Study Completion: 2007-12
• Last Update Submitted: 2007-12-18
• Last Update Posted: 2007-12-21

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age 18 to 65 years old

• PFO with one or more of:

  • Cryptogenic stroke,
  • TIA or embolism,
  • History of severe migraine headaches, or
  • History of severe decompression illness.

Exclusion Criteria

• In appropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PFO closure at 6 months post procedure.	6 months post procedure

Secondary Outcome Measures

Name	Time	Method
PFO closure at 30 days and 12 months post procedure. AE event rate for all subjects. Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine.	30 days; 6 and 12 months

Trial Locations

Locations (1)

Cardiovascular Center Frankfurt Sankt katharinen; 🇩🇪 Frankfurt, Germany