Stitch Closure of PFO and Septal Repair (STITCH)

Foramen Ovale, Patent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05025475
• Other study ID #: 17-2871
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 31, 2026

Study information

• Verified date: August 2023
• Source: Nobles Medical Technologies II Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 640
• Est. completion date: January 31, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• NobleStitch EL
Closure of PFO using NobleStitch EL Closure System
• Amplatzer
Closure of PFO with FDA approved Amplatazer PFO closure device

Locations

Country	Name	City	State
Italy	Ospedale S. Eugenio	Rome	Lazio
United States	Inova Structural Heart Disease Program - Fairfax	Fairfax	Virginia
United States	Tampa General Hospital	Tampa	Florida
United States	TMC HealthCare	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Nobles Medical Technologies II Inc

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Migraine	Rate of Patients who have Experience Improvement in Migraine	4-6 weeks, 6 months, 1 year, and annually up to five years
Primary	Closure Rates of PFO and ASD	Saline Contrast Echo	12 months
Secondary	Recurrent Stroke Rate	Rate of which Patient Experiences Recurrent Stroke	4-6 weeks, 6 months, 1 year, and annualy up to five years