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

Recruiting in Palo Alto (17 mi)

+38 other locations

Himanshu Patel - University of Michigan ...

Overseen ByMichael M Dake, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: W.L.Gore & Associates

No Placebo Group

Trial Summary

What is the purpose of this trial?The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation of the device.

Eligibility Criteria

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.

Inclusion Criteria

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

My aorta is suitable for surgery near the aneurysm.

I need surgery for a thoracic aortic issue requiring a graft in the upper chest area.

I am 18 years old or older.

My body is suitable for the specific medical procedure.

Exclusion Criteria

My aorta is infected.

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

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

I have an infection in the wall of my artery.

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

I have a history of blood clotting disorders.

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

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

I have had a procedure to fix my ascending aorta.

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

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

Participant Groups

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.

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.