← Back to Search

Endovascular Device

GORE TBE Device for Aortic Lesion (SSB 11-02 Trial)

N/A
Waitlist Available
Led By Michael M Dake, 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
Must have appropriate proximal aortic landing zone
For patients with aneurysm/isolated lesion, must have appropriate distal 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 a new device 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 thoracic aortic lesions needing surgical repair, who can follow the study's requirements. They must have suitable areas in their aorta for device placement but no infections, recent drug abuse, or conditions like Marfan's Syndrome. Pregnant women and those with certain allergies or medical conditions that affect imaging quality are excluded.Check my eligibility
What is being tested?
The GORE® TAG® Thoracic Branch Endoprosthesis is being tested to see if it's safe and effective for treating aortic arch and descending thoracic aorta lesions when implanted in Zone 2 of the aorta.See study design
What are the potential side effects?
Potential side effects may include complications related to device implantation such as blood vessel damage, bleeding, infection risk at the graft site, allergic reactions to materials in the endoprosthesis, or issues due to contrast media used during surgery.

SSB 11-02 Trial Eligibility Criteria

Inclusion Criteria

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

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
Proportion of Participants With Primary Endpoint Success for Zone 2

SSB 11-02 Trial Design

2Treatment groups
Experimental Treatment
Group I: Zone 2 Non-aneurysmExperimental Treatment1 Intervention
Includes dissection, traumatic transection and other isolated aortic lesion cohorts. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.
Group II: Zone 2 AneurysmExperimental Treatment1 Intervention
Includes primary (hypothesis-driven) aneurysm cohort and continued access. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.
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
28,079 Total Patients Enrolled
Michael M Dake, MDPrincipal InvestigatorStanford University
Himanshu Patel, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

GORE® TAG® Thoracic Branch Endoprosthesis (Endovascular Device) Clinical Trial Eligibility Overview. Trial Name: NCT02777593 — N/A
Thoracic Aortic Aneurysm Research Study Groups: Zone 2 Aneurysm, Zone 2 Non-aneurysm
Thoracic Aortic Aneurysm Clinical Trial 2023: GORE® TAG® Thoracic Branch Endoprosthesis Highlights & Side Effects. Trial Name: NCT02777593 — N/A
GORE® TAG® Thoracic Branch Endoprosthesis (Endovascular Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02777593 — N/A

Frequently Asked Questions

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

Is this research still looking for participants?

"As reflected on clinicaltrials.gov, this particular trial is not currently accepting candidates for participation. Initially posted on September 6th 2016 and last updated November 1st 2022, the study has concluded its recruitment process; however, 152 other medical studies are presently seeking subjects to join their trials."

Answered by AI

In what geographic regions is this research project taking place?

"Individuals interested in this research endeavour can join at various medical centers including Heart Hospital at Baylor Plano in Plano, Cardiothoracic and Vascular Surgeons in Austin, Research Foundation SUNY Buffalo in Buffalo as well as 34 other sites."

Answered by AI
~29 spots leftby Mar 2025