NobleStitch EL STITCH Trial is a PFO Comparative Trial

NCT ID: NCT04339699

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 640 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2027-06-30

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 the 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.

Conditions

Foramen Ovale, Patent; Stroke, Ischemic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NobleStitch™EL

Participants treated with the NobleStitch™EL device

Group Type: ACTIVE_COMPARATOR

NobleStitch™EL Suture Mediated Closure System

Intervention Type: DEVICE

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

Amplatzer PFO Occluder

Participants treated with the Amplatzer PFO Occluder device

Group Type: ACTIVE_COMPARATOR

Amplatzer PFO Occluder

Intervention Type: DEVICE

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

Interventions

NobleStitch™EL Suture Mediated Closure System

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

Intervention Type: DEVICE

Amplatzer PFO Occluder

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female ages 18 - 60 years old
• A PFO and a Cryptogenic Stroke verified by a neurologist
• Stroke is defined as an acute focal neurological deficit, presumed to be due to focal ischemia, and either:

• Symptoms persisting ≥24 hours, or
• Symptoms persisting <24 hours with Magnetic Resonance or CT findings of a new, neuroanatomical relevant infarct
• Cryptogenic stroke was defined as a stroke of unknown cause
• Prolonged cardiac rhythm monitoring (recommended 30 days and not less than 24 hours required)
• Intra and extracranial artery imaging: Magnetic Resonance Angiography, CT angiography, or contrast angiography, or contrast angiography or echocardiography of the carotid arteries to rule out ischemic stroke associated with atherosclerotic plaque, arterial dissection, or other vascular diseases. (The aortic arch may also be evaluated by TEE).
• Hypercoagulable state assessment to rule out an underlying hypercoagulable state

Exclusion Criteria

• Female participant who is pregnant, lactating or planning a pregnancy during the course of the study
• Age <18 or > 60 years of age
• Previous myocardial infarction or unstable angina within 6 months
• Clinically significant mitral or aortic valve stenosis or severe regurgitation
• Left Ventricular Ejection Fraction <50 percent
• Progressive neurological dysfunction or reduced life expectancy
• Contrast allergy
• Atrial Septal Defect (baseline left to right shunt assessed by TEE or other congenital heart diseases
• Active Endocarditis
• Perspective participants with known causes of Ischemic Stroke
• Arterial dissection
• Contraindicated or unsuitable for antiplatelet agents or oral anticoagulants
• Perspective participants with prosthetic heart valves
• Uncontrolled diabetes Mellitus
• Pulmonary hypertension
• Uncontrolled systemic hypertension
• Intracranial pathology
• Neurological deficits not due to stroke that may affect neurologic assessments
• Active autoimmune disease
• Active infection
• Alcohol and/or drug abuse
• A requirement for chronic anticoagulation therapy that cannot be discontinued
• Anatomic features (inability to achieve vascular access)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nobles Medical Technologies II Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony A Nobles, PhD

Role: STUDY_DIRECTOR

Nobles Medical Technologies II Inc

Locations

TMC HealthCare

Tucson, Arizona, United States

USF/Tampa General Hospital

Tampa, Florida, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Inova Structural Heart Disease Program - Fairfax

Fairfax, Virginia, United States

Ospedale S. Eugenio

Rome, Lazio, Italy

Countries

United States; Italy

References

Gaspardone A, De Marco F, Sgueglia GA, De Santis A, Iamele M, D'Ascoli E, Tusa M, Corciu A, Mullen M, Nobles A, Carminati M, Bedogni F. Novel percutaneous suture-mediated patent foramen ovale closure technique: early results of the NobleStitch EL Italian Registry. EuroIntervention. 2018 Jun 8;14(3):e272-e279. doi: 10.4244/EIJ-D-18-00023.

Reference Type: BACKGROUND

PMID: 29616629 (View on PubMed)

Other Identifiers

748824-0819

Identifier Type: -

Identifier Source: org_study_id

NCT05025475

Identifier Type: -

Identifier Source: nct_alias