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Endovascular Device

Thoracic Branch Endoprosthesis for Aortic Lesions (SSB 11-02 Trial)

N/A
Waitlist Available
Led By Himanshu Patel, MD
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone
Must have appropriate proximal aortic landing zone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

SSB 11-02 Trial Summary

This trial will test whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective for treating aortic arch and descending thoracic aorta lesions.

Who is the study for?
This trial is for adults over 18 with aortic arch or descending thoracic aorta lesions needing surgical repair, who can follow the study plan and have signed consent. It's not for those with recent heart attacks, drug abuse history, allergies to device materials, certain blood conditions, recent surgeries (except specific aortic procedures), pregnancy, participation in other trials within a year, poor imaging due to body habitus, high stroke risk or life expectancy under 2 years.Check my eligibility
What is being tested?
The GORE® TAG® Thoracic Branch Endoprosthesis is being tested for safety and effectiveness in treating lesions of the aortic arch and descending thoracic aorta. The procedure involves placing this endoprosthesis within the affected area of the artery to support it.See study design
What are the potential side effects?
Potential side effects may include but are not limited to: complications from anesthesia or revascularization such as bleeding or infection; allergic reactions to device materials; blood clots; damage to surrounding organs or tissues; and issues related to improper placement or function of the endoprosthesis.

SSB 11-02 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My aorta is suitable for surgery near the aneurysm.
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My heart's main artery has a suitable area for treatment.
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I need surgery for a thoracic aortic issue requiring a graft in the upper chest area.
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I am 18 years old or older.

SSB 11-02 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of Initiation of Index Procedure, Device Technical Success and Adverse Events for Zone 0/1 Subjects (Aneurysm Cohort)

SSB 11-02 Trial Design

2Treatment groups
Experimental Treatment
Group I: Zone 0/1 Non-aneurysm aortic lesionsExperimental Treatment2 Interventions
Includes dissection and other isolated lesion types
Group II: Zone 0/1 Aortic aneurysmExperimental Treatment2 Interventions
Zone 0/1 Aortic aneurysm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GORE® TAG® Thoracic Branch Endoprosthesis
2015
N/A
~40

Find a Location

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor
95 Previous Clinical Trials
28,179 Total Patients Enrolled
Himanshu Patel, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
250 Total Patients Enrolled
Michael Dake, MDPrincipal InvestigatorStanford University
3 Previous Clinical Trials
1,136 Total Patients Enrolled

Media Library

GORE® TAG® Thoracic Branch Endoprosthesis (Endovascular Device) Clinical Trial Eligibility Overview. Trial Name: NCT02777528 — N/A
Aortic Lesion Research Study Groups: Zone 0/1 Aortic aneurysm, Zone 0/1 Non-aneurysm aortic lesions
Aortic Lesion Clinical Trial 2023: GORE® TAG® Thoracic Branch Endoprosthesis Highlights & Side Effects. Trial Name: NCT02777528 — N/A
GORE® TAG® Thoracic Branch Endoprosthesis (Endovascular Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02777528 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many health care institutions are participating in this exploration?

"34 medical centres are currently enrolling for this trial, such as Cooper University Hospital in Camden, Hartford Hospital in Hartford, and Houston Methodist Hospital in Houston."

Answered by AI

How many individuals are enrolled in this clinical research endeavor?

"In order to initiate the study, W.L.Gore & Associates must recruit 150 qualified participants from various sites, such as Cooper University Hospital in Camden and Hartford Hospital in Connecticut."

Answered by AI

Are there any current vacancies for enrollment in this research endeavor?

"Evidently, this trial is actively seeking participants. Judging by the information posted on clinicaltrials.gov, it was initially published on August 1st 2016 with its most recent edit occurring July 22nd 2022."

Answered by AI
~17 spots leftby Mar 2025