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Endovascular Device

GORE TBE Device for Aortic Lesion (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

Must have appropriate proximal aortic landing zone

For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone

Must not have

Infected aorta

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's main artery has a suitable area for treatment.

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My aorta is suitable for surgery near the aneurysm.

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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.

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My body is suitable for the specific medical procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My aorta is infected.

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I have not had a stroke in the last 6 weeks.

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I have irregular blood clots or plaque in my heart's main artery.

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I have an infection in the wall of my artery.

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I have low blood pressure that doesn't improve with treatment.

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I have a history of blood clotting disorders.

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My kidney function is very low or I am on dialysis.

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I cannot have certain procedures due to narrow or twisted arteries in my legs.

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I have had a procedure to fix my ascending aorta.

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I have a condition like Marfan's or Ehler-Danlos Syndrome.

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I need surgery for an aneurysm in my chest or belly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Participants With Primary Endpoint Success for Zone 2

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 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

0 / 16Eligibility criteria met