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Trial record 2 of 8 for:    CLOSE PFO stroke

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 : Not yet recruiting
First Posted : April 9, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
HeartStitch.Com

Tracking Information
First Submitted Date  ICMJE April 1, 2020
First Posted Date  ICMJE April 9, 2020
Last Update Posted Date April 16, 2020
Estimated Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2020)
To demonstrate non-inferiority of the NobleStitch EL with medical management in both safety and effectiveness compared to the FDA approved Amplatzer occluder to prevent recurrent ischemic stroke [ 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2020)
To demonstrate that the NobleStitch EL does not increase the incidence of ischemic stroke compared to published medical management data [ 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
Current Other Pre-specified Outcome Measures
 (submitted: April 6, 2020)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE NobleStitch EL STITCH Trial is a PFO Comparative Trial
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Foramen Ovale, Patent
  • Stroke, Ischemic
Intervention  ICMJE
  • Device: NobleStitch EL Suture Mediated Closure System
    Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch EL suture Medicate Closure System
  • Device: Amplatzer PFO Occluder
    Percutaneous closure of Patent Foramen Ovale (PFO) using Amplatzer PFO Occluder
Study Arms  ICMJE
  • Active Comparator: NobleStitch EL
    Participants treated with the NobleStitch EL device
    Intervention: Device: NobleStitch EL Suture Mediated Closure System
  • Active Comparator: Amplatzer PFO Occluder
    Participants treated with the Amplatzer PFO Occluder device
    Intervention: Device: Amplatzer PFO Occluder
Publications * Gaspardone A, De Marco F, Sgueglia GA, De Santis A, Iamele M, D'Ascoli E, Tusa M, Corciu A, Mullen M, Nobles A, Carminati M, Bedogni F. Novel percutaneous suture-mediated patent foramen ovale closure technique: early results of the NobleStitch EL Italian Registry. EuroIntervention. 2018 Jun 8;14(3):e272-e279. doi: 10.4244/EIJ-D-18-00023.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2020)
640
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2026
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04339699
Other Study ID Numbers  ICMJE 748824-0819
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
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
Responsible Party HeartStitch.Com
Study Sponsor  ICMJE HeartStitch.Com
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anthony A Nobles, PhD Nobles Medical Technologies II Inc
PRS Account HeartStitch.Com
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP