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Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)

NCT00201461 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2008-12-30

No results posted yet for this study

Summary

The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compared to best medical therapy.

Conditions

  • Patent Foramen Ovale
  • Stroke
  • Ischemic Attack, Transient

Interventions

DEVICE

STARFlex septal closure system

transcatheter placement of STARFlex device to close a patent foramen ovale

DRUG

Best medical therapy

aspirin (325 mg daily) and/or warfarin (target INR = 2.5)

Sponsors & Collaborators

  • NMT Medical

    lead INDUSTRY

Principal Investigators

  • Anthony Furlan, MD · Cleveland Clinic Foundation, Cleveland, OH

  • Mark Reisman, MD · Swedish Medical Center, Seattle, WA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-06-30
Completion
2010-04-30

Countries

  • United States

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 NCT00201461 on ClinicalTrials.gov