Recruiting

NobleStitch EL vs. Amplatzer Occluder

Sponsor:

Nobles Medical Technologies II Inc

Code:

NCT04339699

Conditions

Foramen Ovale, Patent

Stroke, Ischemic

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

NobleStitch™EL Suture Mediated Closure System

Amplatzer PFO Occluder

Study Details

Brief summary:

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.

Conditions

Foramen Ovale, Patent

Stroke, Ischemic

Study ID

NCT04339699

Start date

Jan 1, 2021

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female ages 18 - 60 years old
  • A PFO and a Cryptogenic Stroke verified by a neurologist
  • Stroke is defined as an acute focal neurological deficit, presumed to be due to focal ischemia, and either:

  • Symptoms persisting ≥24 hours, or
  • Symptoms persisting <24 hours with Magnetic Resonance or CT findings of a new, neuroanatomical relevant infarct
  • Cryptogenic stroke was defined as a stroke of unknown cause
  • Prolonged cardiac rhythm monitoring (recommended 30 days and not less than 24 hours required)
  • Intra and extracranial artery imaging: Magnetic Resonance Angiography, CT angiography, or contrast angiography, or contrast angiography or echocardiography of the carotid arteries to rule out ischemic stroke associated with atherosclerotic plaque, arterial dissection, or other vascular diseases. (The aortic arch may also be evaluated by TEE).
  • Hypercoagulable state assessment to rule out an underlying hypercoagulable state

Exclusion Criteria:

  • Female participant who is pregnant, lactating or planning a pregnancy during the course of the study
  • Age <18 or > 60 years of age
  • Previous myocardial infarction or unstable angina within 6 months
  • Clinically significant mitral or aortic valve stenosis or severe regurgitation
  • Left Ventricular Ejection Fraction <50 percent
  • Progressive neurological dysfunction or reduced life expectancy
  • Contrast allergy
  • Atrial Septal Defect (baseline left to right shunt assessed by TEE or other congenital heart diseases
  • Active Endocarditis
  • Perspective participants with known causes of Ischemic Stroke
  • Arterial dissection
  • Contraindicated or unsuitable for antiplatelet agents or oral anticoagulants
  • Perspective participants with prosthetic heart valves
  • Uncontrolled diabetes Mellitus
  • Pulmonary hypertension
  • Uncontrolled systemic hypertension
  • Intracranial pathology
  • Neurological deficits not due to stroke that may affect neurologic assessments
  • Active autoimmune disease
  • Active infection
  • Alcohol and/or drug abuse
  • A requirement for chronic anticoagulation therapy that cannot be discontinued
  • Anatomic features (inability to achieve vascular access)

Study Design

Enrollment

640 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

NobleStitch™EL Suture Mediated Closure System

Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch™EL suture Medicate Closure System

Amplatzer PFO Occluder

Percutaneous closure of Patent Foramen Ovale (PFO) using Amplatzer PFO Occluder

Primary outcome measure

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

Central Contacts and Locations

Central contacts

James A Thompson, MD

727-767-7328jthomp80@jhmi.edu

Anthony Nobles, Phd

714-427-0398anobles@noblesmed2.com

Locations

TMC HealthCare

Recruiting

Tucson, Arizona, United States, 85712

Contacts

Natalia E Calles, MPH

520-324-5512natalia.eliascalles@tmcaz.com

Principal Investigator:

Thomas Waggoner, MD

More Information

Sponsor

Nobles Medical Technologies II Inc

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • Patent Foramen Ovale
  • Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nobles Medical Technologies II Inc on 2026-03-23.