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)

Active, not recruiting

Phase 2/3 Results N/A

Trial Description

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

Interventions

  • Best Medical Therapy Drug
    Intervention Desc: aspirin (325 mg daily) and/or warfarin (target INR = 2.5)
    ARM 1: Kind: Experimental
    Label: 1
    Description: Best medical therapy
  • STARFlex septal closure system Device
    Intervention Desc: transcatheter placement of STARFlex device to close a patent foramen ovale
    ARM 1: Kind: Experimental
    Label: 2
    Description: STARFlex arm

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to receive the STARFlex device or best medical therapy. All patients will be asked to participate in a phone call at 1 month and visits to their study neurologist at 6 months, 12 months and 24 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary endpoint is the 2 year incidence of stroke or TIA. Also, all cause mortality for the first 30 days of follow up or hospital discharge, whichever is longer. And, neurological mortality from 31 days of follow up or longer.
Secondary Incidence of primary endpoint - total, as well as broken down by event type (i.e. stroke, TIA, mortality) per treatment group. Incidence of primary endpoint (as a total and broken down by event type) in the best medical therapy group in patients. Per medical treatment group: adverse events, incidence of clinical changes, incidence of migraine headaches. For device group: adverse events, device success, procedural success, effective closure rate.
Primary Two (2) year incidence of stroke or Hard TIA 2 years No
Primary All cause mortality for the first 30 days of follow up/discharge, whichever is longer 30 days Yes
Primary Neurological mortality from 31 days of follow up (F/U) or longer 31 days Yes
Secondary Incidence of primary endpoint as a total and broken down by event type/treatment group in: stroke/TIA patients (pts) and DW-MR+ pts with symptoms < 24 hours < 24 hrs Yes
Secondary Incidence of primary endpoint in BMT group 2 years Yes
Secondary Per treatment group, incidence of relevant/notable adverse events (AEs) 2 years Yes
Secondary Device group: (1) Incidence of primary endpoint in pts prescribed aspirin (325 versus 81 mg) daily, (2) Incidence of relevant/notable AEs 2 years Yes

Sponsors