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Endovascular Device

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

N/A
Waitlist Available
Led By Michael 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
For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone
Must have appropriate proximal aortic landing zone
Must not have
Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin
Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a stroke in the last 6 weeks.
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I need surgery for an aneurysm in my chest or abdomen.
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My blood pressure is often below 90 mm Hg despite treatment.
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My aorta is infected.
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I have a history of blood clotting disorders.
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I cannot have certain procedures due to narrow or twisted arteries in my legs.
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I have a condition like Marfan's or Ehler-Danlos Syndrome.
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My kidney function is very low or I am on dialysis.
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I am at high risk for a stroke or similar brain event.
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I have had a procedure to fix my ascending aorta without open surgery.
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I have an infection-caused bulge in my blood vessel wall.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
100 Previous Clinical Trials
32,639 Total Patients Enrolled
Michael Dake, MDPrincipal InvestigatorStanford University
3 Previous Clinical Trials
1,136 Total Patients Enrolled
Himanshu Patel, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

GORE® TAG® Thoracic Branch Endoprosthesis (Endovascular Device) Clinical Trial Eligibility Overview. Trial Name: NCT02777528 — N/A
Thoracic Aortic Aneurysm Research Study Groups: Zone 0/1 Aortic aneurysm, Zone 0/1 Non-aneurysm aortic lesions
Thoracic Aortic Aneurysm 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
~16 spots leftby Dec 2025
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