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GORE TBE Device for Aortic Lesion (SSB 11-02 Trial)
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.
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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- You have had a bad reaction to heparin in the past, or have a condition called Heparin Induced Thrombocytopenia type 2 (HIT-2).My aorta is infected.You are not expected to live for more than 2 years.You have had a different type of device used to repair your DTA in the past.I have a systemic infection that could risk graft infection.My heart's main artery has a suitable area for treatment.My aorta is suitable for surgery near the aneurysm.I haven't had surgery in the last 30 days, except for specific heart or vascular procedures.I have not had a stroke in the last 6 weeks.You have used drugs in the past year.I have irregular blood clots or plaque in my heart's main artery.My treatment plan includes covering the celiac artery.You have a known severe allergy or cannot safely take blood thinners or contrast dye.I have an infection in the wall of my artery.I need surgery for a thoracic aortic issue requiring a graft in the upper chest area.I am 18 years old or older.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.You have a medical condition or body shape that makes it hard to see your aorta clearly.My body is suitable for the specific medical procedure.The size of the aorta is not suitable for the device, and no other devices can be used to make it fit.I have not had a heart attack in the last 6 weeks.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.
- Group 1: Zone 2 Aneurysm
- Group 2: Zone 2 Non-aneurysm
- 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
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."
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."
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