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NobleStitch EL STITCH Trial is a PFO Comparative Trial

NCT04339699 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Foramen Ovale, Patent
  • Stroke, Ischemic

Interventions

DEVICE

NobleStitch™EL Suture Mediated Closure System

Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch™EL suture Medicate Closure System

DEVICE

Amplatzer PFO Occluder

Percutaneous closure of Patent Foramen Ovale (PFO) using Amplatzer PFO Occluder

Sponsors & Collaborators

  • Nobles Medical Technologies II Inc

    lead INDUSTRY

Principal Investigators

  • Anthony A Nobles, PhD · Nobles Medical Technologies II Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States
  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04339699 on ClinicalTrials.gov