NobleStitch EL STITCH Trial is a PFO Comparative Trial

Stroke, Ischemic Clinical Trial

— STITCH  

Official title:

STITCH - Prospective Multi Center Comparative Parallel Concurrent Study of the NobleStitch EL Compared to FDA Approved Amplatzer Occluder Device for Closure of Patent Foramen Ovale to Prevent Recurrent Ischemic Stroke

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04339699
• Other study ID #: 748824-0819
• Status: Suspended
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 30, 2027

Study information

• Verified date: October 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 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.

Other known NCT identifiers

• NCT05025475

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 640
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Device:
• NobleStitch™EL Suture Mediated Closure System
Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch™EL suture Medicate Closure System
• Amplatzer PFO Occluder
Percutaneous closure of Patent Foramen Ovale (PFO) using Amplatzer PFO Occluder

Locations

Country	Name	City	State
Italy	Ospedale S. Eugenio	Roma	Lazio
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Inova Structural Heart Disease Program - Fairfax	Fairfax	Virginia
United States	USF/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, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The occurrence of recurrent ischemic stroke post procedural of patent foramen ovale closure	Examination of Recurrent Ischemic Stroke through 5 year follow up. Comparison of the rate of Stroke associated with the NobleStitch EL procedure to that expected with medical management	5 Years
Primary	Effective PFO closure rate of the NobleStitch EL	Effectiveness PFO closure rate of NobleStitch EL suture mediated closure with medical management compared to Amplatzer PFO occluder with medical management for PFO closure. Effective PFO closure rate defined as Grade 0 or 1 shunt at rest and during Valsalva at 6 month post closure attempts	6 months
Secondary	Decreased event rate of recurrent ischemic stroke following PFO closure using NobleStitch EL	Safety of NobleStitch EL suture mediated closure system as compared to Amplatzer PFO Occluder Procedural and device related adverse event rate at 6 month follow up recurrent ischemic stroke through 5 years follow up	5 years