NobleStitch EL STITCH Trial is a PFO Comparative Trial

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Nobles Medical Technologies II Inc
Study ID
NCT04339699
Status
Recruiting
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Conditions

  • Foramen Ovale, Patent
  • Stroke, Ischemic

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • NobleStitch™EL Suture Mediated Closure System — DEVICE
    Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch™EL suture Medicate Closure System
  • Amplatzer PFO Occluder — DEVICE
    Percutaneous closure of Patent Foramen Ovale (PFO) using Amplatzer PFO Occluder

Study Details

STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.

Key Dates

Start date
Jan 1, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
640 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: NobleStitch™EL
    Participants treated with the NobleStitch™EL device
  • Active Comparator: Amplatzer PFO Occluder
    Participants treated with the Amplatzer PFO Occluder device

Primary Outcome Measure

Effective PFO closure rate of the NobleStitch EL [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
TMC HealthCareTucsonArizona85712
Natalia E Calles, MPH
[email protected]
520-324-5512
Thomas Waggoner, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tucson, AZ

By research site
TMC HealthCare· Tucson, AZ

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