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Stitch Closure of PFO and Septal Repair (STITCH)

Primary Purpose

Foramen Ovale, Patent, Septal Defect, Atrial, Septal Defect, Heart

Status
Enrolling by invitation
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NobleStitch EL
Amplatzer
Sponsored by
Nobles Medical Technologies II Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foramen Ovale, Patent

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TMC HealthCare
  • Tampa General Hospital
  • Inova Structural Heart Disease Program - Fairfax
  • Ospedale S. Eugenio

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

PFO Closure Rate

Published PFO Device Closure

Arm Description

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.

Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials

Outcomes

Primary Outcome Measures

Closure Rates of PFO and ASD
Saline Contrast Echo

Secondary Outcome Measures

Recurrent Stroke Rate
Rate of which Patient Experiences Recurrent Stroke

Full Information

First Posted
August 23, 2021
Last Updated
August 2, 2022
Sponsor
Nobles Medical Technologies II Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05025475
Brief Title
Stitch Closure of PFO and Septal Repair (STITCH)
Official Title
Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nobles Medical Technologies II Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foramen Ovale, Patent, Septal Defect, Atrial, Septal Defect, Heart

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-randomized, single-center, observational study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PFO Closure Rate
Arm Type
Other
Arm Description
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.
Arm Title
Published PFO Device Closure
Arm Type
Active Comparator
Arm Description
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials
Intervention Type
Device
Intervention Name(s)
NobleStitch EL
Other Intervention Name(s)
Suture Mediated PFO Clsoure and Septal Repair
Intervention Description
Closure of PFO using NobleStitch EL Closure System
Intervention Type
Device
Intervention Name(s)
Amplatzer
Other Intervention Name(s)
Closure of PFO using septal occluder
Intervention Description
Closure of PFO with FDA approved Amplatazer PFO closure device
Primary Outcome Measure Information:
Title
Closure Rates of PFO and ASD
Description
Saline Contrast Echo
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Recurrent Stroke Rate
Description
Rate of which Patient Experiences Recurrent Stroke
Time Frame
4-6 weeks, 6 months, 1 year, and annualy up to five years
Other Pre-specified Outcome Measures:
Title
Migraine
Description
Rate of Patients who have Experience Improvement in Migraine
Time Frame
4-6 weeks, 6 months, 1 year, and annually up to five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony A Nobles, PhD
Organizational Affiliation
Nobles Medical Technologies II Inc
Official's Role
Study Director
Facility Information:
Facility Name
TMC HealthCare
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Inova Structural Heart Disease Program - Fairfax
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Ospedale S. Eugenio
City
Rome
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Stitch Closure of PFO and Septal Repair (STITCH)

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