NobleStitch EL STITCH Trial is a PFO Comparative Trial

Nobles Medical Technologies II

Status: Suspended

Conditions: Foramen Ovale, Patent; Stroke, Ischemic

Treatments: Device: Amplatzer PFO Occluder; Device: NobleStitch™EL Suture Mediated Closure System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04339699

748824-0819

Details and patient eligibility

About

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.

Full 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.

Enrollment: 640 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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640 participants in 2 patient groups

NobleStitch™EL

Active Comparator group

Description:

Participants treated with the NobleStitch™EL device

Treatment:

Device: NobleStitch™EL Suture Mediated Closure System

Amplatzer PFO Occluder

Active Comparator group

Description:

Participants treated with the Amplatzer PFO Occluder device

Treatment:

Device: Amplatzer PFO Occluder