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

Stroke Clinical Trial

— Paradigm IV  

Official title:

The Paradigm IV Trial - PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00529945
• Other study ID #: CA0012
• Status: Suspended
• Phase: N/A
• First received: September 12, 2007
• Last updated: December 18, 2007
• Start date: August 2007
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: Cierra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Decompression Illness
• Ischemia
• Ischemic Attack, Transient
• Migraine
• Migraine Disorders
• PFO
• Stroke
• Transient Ischemic Attack

Intervention

Device:
• PFx Closure System

Locations

Country	Name	City	State
Germany	Cardiovascular Center Frankfurt Sankt katharinen	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Cierra

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFO closure at 6 months post procedure.		6 months post procedure	Yes
Secondary	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	Yes