New technique for repairing thoracic aortic conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and preliminary effectiveness of a novel hybrid repair technique called Branched Stented Anastomosis Frozen Elephant Trunk Repair (B-SAFER) for patients with thoracic aortic pathologies. It focuses on individuals requiring repair of the aortic arch proximal to the innominate artery, utilizing a physician-modified endovascular stentgraft. The study is a prospective, single-center, non-blind, non-randomized investigation that will assess the functionality of the device and its components during the implantation process.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. At least 18 years of age
2. Subject is willing and able to give written informed consent to participate in the study or the subject's legally authorized representative has given written informed consent for the subject to participate in the study.
3. Expected life expectancy of greater than two years after repair
4. Subject has aortic pathology and requires repair or replacement of multiple damaged or diseased segments of the thoracic aorta (at least one of the following condition): Thoracic aortic aneurysm considered at increased risk for rupture or complications, Acute aortic dissection requiring urgent repair, Congenital aortic disease requiring repair

Exclusion Criteria:

1. Subject is unfit for open surgical repair involving circulatory arrest
2. Subject is comatose or suffering from irreversible severe brain malperfusion
3. Subject has known sensitivity to components of the devices
4. Subject has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
5. Subject is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study
6. Subject has an uncorrectable bleeding anomaly
7. Subject has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post- procedure
8. Subject is pregnant

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Eric Roselli, M. D. — The Cleveland Clinic
• Study coordinator: Eric Roselli, M. D.
• Email: roselle@ccf.rg
• Phone: 216-444-0995

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pregnancy-Related Aortic Dissection in China

  This study looks at cases of aortic dissection that occur during pregnancy or shortly after, to understand outcomes for mothers and babies.

  Recruiting at 4 sites DeltaHealth Hospital · Shanghai · Shanghai, Shanghai Municipality and 3 other locations · NCT07672210

• GORE MBA Arch Endoprosthesis Early Feasibility Study

  This study tests the safety of the MBA device in people with arch-related thoracic aortic diseases to see if it can be used safely in real-world settings.

  Recruiting at 3 sites W.L.Gore & Associates · Los Angeles, California and 2 other locations · NCT07564375

• See if spironolactone can reduce aortic stiffness in adults with thoracic aortic aneurysm

  This study tests whether spironolactone reduces aortic stiffness compared with placebo in adults with degenerative thoracic aortic aneurysms.

  Recruiting Phase 1/2 Mayo Clinic · Rochester, Minnesota · NCT07483177

• Ketorolac to improve outcomes and prognosis in Stanford Type A aortic dissection

  This trial will test whether giving ketorolac around emergency surgery helps adults (18–65) with Stanford Type A aortic dissection recover better and have fewer complications over 90 days.

  Recruiting Phase 3 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT06968806

• WeFlow-EndoPatch for Distal Aortic Tear Repair in Chronic Dissection

  This study tests whether the WeFlow-EndoPatch Aortic Endovascular Patch can safely and effectively seal distal tears in chronic aortic dissection compared with standard treatment.

  Recruiting Hangzhou Endonom Medtech Co., Ltd. · Beijing, Beijing Municipality · NCT06945809

• Aortic arch single-branch covered stent graft for treating aortic dissection

  This trial tests a single-branch covered stent graft in adults with Stanford Type B aortic dissection who need revascularization of the left subclavian artery.

  Recruiting Lifetech Scientific (Shenzhen) Co., Ltd. · Changsha · NCT06915545

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.