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NobleStitch EL STITCH Trial is a PFO Comparative Trial (STITCH)

Primary Purpose

Foramen Ovale, Patent, Stroke, Ischemic

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

NobleStitch™EL Suture Mediated Closure System

Amplatzer PFO Occluder

About this trial

This is an interventional treatment trial for Foramen Ovale, Patent focused on measuring Patent Foramen Ovale, Stroke

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

TMC HealthCareRecruiting
USF/Tampa General HospitalRecruiting
Lehigh Valley Health NetworkRecruiting
Inova Structural Heart Disease Program - FairfaxRecruiting
Ospedale S. EugenioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

NobleStitch™EL

Amplatzer PFO Occluder

Arm Description

Participants treated with the NobleStitch™EL device

Participants treated with the Amplatzer PFO Occluder device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04339699

First Posted

April 1, 2020

Last Updated

October 20, 2023

Sponsor

Nobles Medical Technologies II Inc

1. Study Identification

Unique Protocol Identification Number

NCT04339699

Brief Title

NobleStitch EL STITCH Trial is a PFO Comparative Trial

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

December 31, 2026 (Anticipated)

Study Completion Date

June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nobles Medical Technologies II Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Foramen Ovale, Patent, Stroke, Ischemic

Keywords

Patent Foramen Ovale, Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NobleStitch™EL

Arm Type

Active Comparator

Arm Description

Participants treated with the NobleStitch™EL device

Arm Title

Amplatzer PFO Occluder

Arm Type

Active Comparator

Arm Description

Participants treated with the Amplatzer PFO Occluder device

Intervention Type

Device

Intervention Name(s)

NobleStitch™EL Suture Mediated Closure System

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Amplatzer PFO Occluder

Intervention Description

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

Primary Outcome Measure Information:

Title

Effective PFO closure rate of the NobleStitch EL

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Decreased event rate of recurrent ischemic stroke following PFO closure using NobleStitch EL

Description

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

The occurrence of recurrent ischemic stroke post procedural of patent foramen ovale closure

Description

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

Time Frame

5 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

James A Thompson, MD

Phone

727-767-7328

jthomp80@jhmi.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Anthony Nobles, Phd

Phone

714-427-0398

anobles@noblesmed2.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony A Nobles, PhD

Organizational Affiliation

Nobles Medical Technologies II Inc

Official's Role

Study Director

Facility Information:

Facility Name

TMC HealthCare

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Natalia E Calles, MPH

Phone

520-324-5512

natalia.eliascalles@tmcaz.com

First Name & Middle Initial & Last Name & Degree

Thomas Waggoner, MD

Facility Name

USF/Tampa General Hospital

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mia Eifrid

Phone

813-884-8544

miaeifrid@usf.edu

First Name & Middle Initial & Last Name & Degree

Vlastibor Minarovjeck

minarovjech@usf.edu

First Name & Middle Initial & Last Name & Degree

Bibhu D Mohanty, MD

Facility Name

Lehigh Valley Health Network

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tom Eames, RN

Phone

610-402-9543

Thomas.Eames@lvhn.org

First Name & Middle Initial & Last Name & Degree

Dzanan Ramic, MD

Phone

610-402-9543

Dzanan.Ramic@lvhn.org

Facility Name

Inova Structural Heart Disease Program - Fairfax

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathleen Griffen, BHSA

Phone

703-776-3135

Kathleen.Griffen@inova.org

First Name & Middle Initial & Last Name & Degree

Wayne Batchelor, MD

Facility Name

Ospedale S. Eugenio

City

Roma

State/Province

Lazio

ZIP/Postal Code

00144

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tarsia Carmela, MD

Phone

+390651002864

tarsiacarmen@gmail.com

First Name & Middle Initial & Last Name & Degree

Achille Gaspardone, MD

Phone

+390651002864

achille.gaspardone@aslroma2.it

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data (IPD) from the completed STITCH clinical trial that underlie the results reported in the Study, shall after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Immediately the following publication and ending 24 months after publication

IPD Sharing Access Criteria

Will be available to Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. It will be available for Individual participant data meta-analysis

Citations:

PubMed Identifier

29616629

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.

Results Reference

background

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