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Thoracic Branch Endoprosthesis for Aortic Lesions (SSB 11-02 Trial)
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.
SSB 11-02 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSSB 11-02 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SSB 11-02 Trial Design
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Who is running the clinical trial?
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- I have not had a stroke in the last 6 weeks.I need surgery for an aneurysm in my chest or abdomen.I have not had any surgery in the last 30 days, except for specific heart or vascular access procedures.My aorta is suitable for surgery near the aneurysm.You have had a bad reaction to heparin in the past.My treatment plan includes covering the celiac artery.You are allergic to blood thinners or contrast dyes and cannot be treated before the study.You have used drugs in the past year.My blood pressure is often below 90 mm Hg despite treatment.My aorta is infected.Your blood vessels must be the right size and in the right place for the treatment to work.I have a history of blood clotting disorders.I cannot have certain procedures due to narrow or twisted arteries in my legs.Your body shape or other health condition makes it difficult to see your aorta clearly.I have a condition like Marfan's or Ehler-Danlos Syndrome.My kidney function is very low or I am on dialysis.The doctor thinks that it's risky for you to have traditional surgery for a specific area in your body.I have not had a heart attack in the last 6 weeks.I am at high risk for a stroke or similar brain event.You are not expected to live more than 2 years.You have a natural aortic valve and are in Zone 0 or Zone 1.My heart's main artery has a suitable area for treatment.I have had a procedure to fix my ascending aorta without open surgery.You have a protruding or irregular blood clot or fatty deposit in the main artery of your heart.I have a systemic infection that could risk graft infection.The size difference between the top and bottom of the aorta is too big and cannot be fixed with different-sized devices.You have had a surgery to repair the descending thoracic aorta using a non-Gore device in the past.I need surgery for a thoracic aortic issue requiring a graft in the upper chest area.I have an infection-caused bulge in my blood vessel wall.I am 18 years old or older.
- Group 1: Zone 0/1 Aortic aneurysm
- Group 2: Zone 0/1 Non-aneurysm aortic lesions
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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