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Recruiting NCT04339699

NobleStitch EL STITCH Trial is a PFO Comparative Trial

No phase Interventional Foramen Ovale, Patent Stroke, Ischemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NobleStitch™EL Suture Mediated Closure System, Amplatzer PFO Occluder.
Who it may be relevant to
Registry conditions: Foramen Ovale, Patent, Stroke, Ischemic. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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

Primary outcome measures

  • Effective PFO closure rate of the NobleStitch EL [Time frame: 6 months]
Secondary outcome measures (1)
  • Decreased event rate of recurrent ischemic stroke following PFO closure using NobleStitch EL [Time frame: 5 years]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • TMC HealthCare — Tucson
Italy · 1 center
  • Ospedale S. Eugenio — Rome

Publications

  • 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. PMID 29616629

Identifiers

NCT: NCT04339699 · 748824-0819

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗