PFx Closure System in Subjects With Cryptogenic Stroke, T... | NCT00529945

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

NCT00529945

Sponsor

Cierra

Status

Suspended

Last Update Posted

Dec 21, 2007Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

PFO
Stroke
Transient Ischemic Attack
Migraine
Decompression Illness

Interventions

PFx Closure System

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Not provided

Completion Date

Dec 2007Estimated

First Submitted Date

Sep 12, 2007

First Submission Date that Met QC Criteria

Sep 13, 2007

First Posted Date

Sep 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2007

Last Update Posted Date

Dec 21, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
PFx Closure System	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFO closure at 6 months post procedure.		6 months post procedure

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Horst Sievert, MD	Cardiovascular Center Frankfurt, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Center Frankfurt Sankt katharinen		Frankfurt		60389	Germany

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D002546	Ischemic Attack, Transient
D008881	Migraine Disorders

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided