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NobleStitch EL STITCH Trial is a PFO Comparative Trial (STITCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04339699
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : April 22, 2021
Information provided by (Responsible Party):

Brief Summary:
The purpose of the study is to collect data on the NobleStitch EL suture mediated closure system to safely and effectively close a Patent Foramen Ovale (PFO) to reduce the risk of recurrent Ischemic Stroke. The data collected will be compared to PFO closure using the FDA approved Amplatzer Occluder device.

Condition or disease Intervention/treatment Phase
Foramen Ovale, Patent Stroke, Ischemic Device: NobleStitch EL Suture Mediated Closure System Device: Amplatzer PFO Occluder Not Applicable

Detailed Description:
Prospective Multi Center Comparative parallel concurrent study of the NobleStitch EL as compared to the FDA approved Amplatzer Occluder device for closure of Patent Foramen Ovale (PFO) to prevent recurrent Ischemic Stroke.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A 640 participants indicated for percutaneous transcatheter closure of a PFO to reduce risk of recurrent Ischemic Stroke; between ages 18 - 60 years, who have had a Cryptogenic Stroke due to Paradoxical Embolism. To be conducted both in the USA and the European Union.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STITCH - Prospective Multi Center Comparative Parallel Concurrent Study of the NobleStitch EL Compared to FDA Approved Amplatzer Occluder Device for Closure of Patent Foramen Ovale to Prevent Recurrent Ischemic Stroke
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : April 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arm Intervention/treatment
Active Comparator: NobleStitch EL
Participants treated with the NobleStitch EL device
Device: NobleStitch EL Suture Mediated Closure System
Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch EL suture Medicate Closure System

Active Comparator: Amplatzer PFO Occluder
Participants treated with the Amplatzer PFO Occluder device
Device: Amplatzer PFO Occluder
Percutaneous closure of Patent Foramen Ovale (PFO) using Amplatzer PFO Occluder

Primary Outcome Measures :
  1. Effective PFO closure rate of the NobleStitch EL [ Time Frame: 6 months ]
    Effectiveness PFO closure rate of NobleStitch EL suture mediated closure with medical management compared to Amplatzer PFO occluder with medical management for PFO closure. Effective PFO closure rate defined as Grade 0 or 1 shunt at rest and during Valsalva at 6 month post closure attempts

Secondary Outcome Measures :
  1. Decreased event rate of recurrent ischemic stroke following PFO closure using NobleStitch EL [ Time Frame: 5 years ]
    Safety of NobleStitch EL suture mediated closure system as compared to Amplatzer PFO Occluder Procedural and device related adverse event rate at 6 month follow up recurrent ischemic stroke through 5 years follow up

Other Outcome Measures:
  1. The occurrence of recurrent ischemic stroke post procedural of patent foramen ovale closure [ Time Frame: 5 Years ]
    Examination of Recurrent Ischemic Stroke through 5 year follow up. Comparison of the rate of Stroke associated with the NobleStitch EL procedure to that expected with medical management

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339699

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Contact: James A Thompson, MD 703-876-8410 Jim_Thompson@MEDNAX.com
Contact: Stephanie M Garafalo, RN BSN CCRC 708-776-2018 Stephanie.Garafalo@inova.org

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United States, Virginia
Inova Cardiovascular Institute Recruiting
Falls Church, Virginia, United States, 22042
Contact: Stephanie Gerolafo, RN         
Contact: James Thompson, MD         
Principal Investigator: James Thompson, MD         
Sponsors and Collaborators
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Study Director: Anthony A Nobles, PhD Nobles Medical Technologies II Inc
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Responsible Party: HeartStitch.Com
ClinicalTrials.gov Identifier: NCT04339699    
Other Study ID Numbers: 748824-0819
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) from the completed STITCH clinical trial that underlie the results reported in the Study, shall after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Time Frame: Immediately the following publication and ending 24 months after publication
Access Criteria: Will be available to Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. It will be available for Individual participant data meta-analysis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by HeartStitch.Com:
Patent Foramen Ovale
Additional relevant MeSH terms:
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Ischemic Stroke
Foramen Ovale, Patent
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities