PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness (Paradigm IV)

Cierra

Status: Suspended

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

Treatments: Device: PFx Closure System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00529945

CA0012

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)