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

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

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.

Study Overview

• Status: Suspended
• Conditions: Foramen Ovale, Patent; Stroke, Ischemic
• Intervention / Treatment: Device: Amplatzer PFO Occluder; Device: NobleStitch™EL Suture Mediated Closure System

Detailed Description

To demonstrate the non-inferiority of the NobleStitch™ EL with medical management in both safety and effectiveness compared to the FDA-approved Amplatzer Occluder with medical management for PFO Closure.

To demonstrate that the NobleStitch EL does not increase the incidence of ischemic stroke compared to published medical management data.

• Study Type: Interventional
• Enrollment (Estimated): 640
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James A Thompson, MD; Phone Number: 727-767-7328; Email: jthomp80@jhmi.edu
• Study Contact Backup: Name: Anthony Nobles, Phd; Phone Number: 714-427-0398; Email: anobles@noblesmed2.com

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00144
      • Ospedale S. Eugenio
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • TMC Healthcare
  • Florida
    • Tampa, Florida, United States, 33606
      • USF/Tampa General Hospital
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
  • Virginia
    • Fairfax, Virginia, United States, 22042
      • Inova Structural Heart Disease Program - Fairfax

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective PFO closure rate of the NobleStitch EL	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreased event rate of recurrent ischemic stroke following PFO closure using NobleStitch EL	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	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of recurrent ischemic stroke post procedural of patent foramen ovale closure	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	5 Years

Collaborators and Investigators

• Sponsor: Nobles Medical Technologies II Inc
• Investigators: Study Director: Anthony A Nobles, PhD, Nobles Medical Technologies II Inc

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Patent Foramen Ovale
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Stroke; Ischemic Stroke; Foramen Ovale, Patent
• Other Study ID Numbers: 748824-0819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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).
• IPD Sharing Time Frame: Immediately the following publication and ending 24 months after publication
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes