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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05025475
Other study ID # 17-2871
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
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Enrolling by invitation NCT03373929 - Stitch Closure of PFO and Septal Repair N/A
Completed NCT02432131 - Decompression Sickness in Divers With or Without Patent Foramen Ovale
Recruiting NCT04987008 - Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale
Recruiting NCT04881578 - Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study
Completed NCT02400892 - Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries N/A
Recruiting NCT01385670 - InterSEPT: In‐Tunnel SeptRx European PFO Trial N/A
Completed NCT02957201 - The Effect on EPCs by Successful Cardiac Occlusion Device Implantation N/A
Completed NCT00968032 - Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System N/A
Recruiting NCT05558774 - Long-term Outcomes After Percutaneous Closure of PFO
Completed NCT02127294 - Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine N/A
Recruiting NCT01149447 - Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale N/A
Suspended NCT04339699 - NobleStitch EL STITCH Trial is a PFO Comparative Trial N/A
Recruiting NCT04713683 - Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder N/A
Withdrawn NCT03232450 - Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation N/A