Clinical trial NCT04339699: NobleStitch EL STITCH Trial is a PFO Comparative Trial
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Foramen Ovale, Patent
Stroke, Ischemic
Keywords: Patent Foramen Ovale
Stroke
Lead sponsor: Nobles Medical Technologies II Inc
Sponsor class: INDUSTRY
First posted: 2020-04-09
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 640 participants indicated for percutaneous transcatheter closure of a PFO to reduce risk of recurrent Ischemic Stroke; between ages 18 - 60 years, who have had a Cryptogenic Stroke due to Paradoxical Embolism. To be conducted both in the USA and the European Union.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Effective PFO closure rate of the NobleStitch EL
timeFrame: 6 months
Secondary outcomes:
measure: Decreased event rate of recurrent ischemic stroke following PFO closure using NobleStitch EL
timeFrame: 5 years
Other outcomes:
measure: The occurrence of recurrent ischemic stroke post procedural of patent foramen ovale closure
timeFrame: 5 Years
Locations:
city: Tucson
country: United States
facility: TMC HealthCare
state: Arizona
city: Tampa
country: United States
facility: USF/Tampa General Hospital
state: Florida
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Fairfax
country: United States
facility: Inova Structural Heart Disease Program - Fairfax
state: Virginia
city: Roma
country: Italy
facility: Ospedale S. Eugenio
state: Lazio
Study officials:
affiliation: Nobles Medical Technologies II Inc
name: Anthony A Nobles, PhD
role: STUDY_DIRECTOR
References:
citation: 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.