NCT04339699

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jan 2021Jun 2027

First Submitted

Initial submission to the registry

April 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

April 1, 2020

Last Update Submit

March 18, 2026

Conditions

Foramen Ovale, PatentStroke, Ischemic

Keywords

Patent Foramen OvaleStroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    5 years

Other Outcomes (1)

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

    5 Years

Study Arms (2)

NobleStitch™EL

ACTIVE COMPARATOR

Participants treated with the NobleStitch™EL device

Device: NobleStitch™EL Suture Mediated Closure System

Amplatzer PFO Occluder

ACTIVE COMPARATOR

Participants treated with the Amplatzer PFO Occluder device

Device: Amplatzer PFO Occluder

Interventions

Amplatzer PFO OccluderDEVICE

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

Amplatzer PFO Occluder
NobleStitch™EL Suture Mediated Closure SystemDEVICE

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

NobleStitch™EL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

TMC HealthCare

Tucson, Arizona, 85712, United States

RECRUITING

Ospedale S. Eugenio

Rome, Lazio, 00144, Italy

RECRUITING

Related 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.

    PMID: 29616629BACKGROUND

MeSH Terms

Conditions

Foramen Ovale, PatentIschemic StrokeStroke

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Anthony A Nobles, PhD

    Nobles Medical Technologies II Inc

    STUDY DIRECTOR

Central Study Contacts

James A Thompson, MD

CONTACT

727-767-7328jthomp80@jhmi.edu

Anthony Nobles, Phd

CONTACT

714-427-0398anobles@noblesmed2.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 9, 2020

Study Start

January 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL
Time Frame
Immediately the following publication and ending 24 months after publication
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

Locations

IT(1)US(1)