Stitch Closure of PFO and Septal Repair (STITCH)

August 18, 2023 updated by: Nobles Medical Technologies II Inc

Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System

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

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

To demonstrate 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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00144
        • Ospedale S. Eugenio
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • TMC Healthcare
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Virginia
      • Fairfax, Virginia, United States, 22042
        • Inova Structural Heart Disease Program - Fairfax

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PFO
  • ASD (less than 1 cm with redundant septal tissue)
  • Trans Septal Puncture Sites
  • ASA (when an appropriate PFO or small ASD defect is present)
  • Stroke
  • Trans Ischemic Attack (TIA)
  • Platypnea Orthodeoxia Syndrome
  • Decompression Illness

Exclusion Criteria:

  • Patients under 18 years and over 65 years of age
  • Patients who are not fluent in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PFO Closure Rate
Evaluate closure rate of clinically relevant septal defects including PFO, ASD (less than 1 cm with redundant septal tissue), transseptal puncture sites, repair of ASA (when an appropriate PFO or small ASD defect is present), and rate of a recurrent neurologic embolic event in patients with cryptogenic stroke and PFO.
Device: NobleStitch EL
Closure of PFO using NobleStitch EL Closure System
Other Names:
  • Suture Mediated PFO Clsoure and Septal Repair
Active Comparator: Published PFO Device Closure
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials
Device: Amplatzer
Closure of PFO with FDA approved Amplatazer PFO closure device
Other Names:
  • Closure of PFO using septal occluder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Closure Rates of PFO and ASD
Time Frame: 12 months
Saline Contrast Echo
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent Stroke Rate
Time Frame: 4-6 weeks, 6 months, 1 year, and annualy up to five years
Rate of which Patient Experiences Recurrent Stroke
4-6 weeks, 6 months, 1 year, and annualy up to five years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine
Time Frame: 4-6 weeks, 6 months, 1 year, and annually up to five years
Rate of Patients who have Experience Improvement in Migraine
4-6 weeks, 6 months, 1 year, and annually up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nobles Medical Technologies II Inc

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-2871

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Foramen Ovale, Patent

Clinical Trials on NobleStitch EL

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe