Clinical Trials Logo

Clinical Trial Summary

A prospective, single-center, non-blind, non-randomized safety and feasibility study of the hybrid repair of thoracic aortic pathologies requiring repair of the aortic arch proximal to the origin of innominate artery.


Clinical Trial Description

The proposed Investigational Device Exemption (IDE) is to assess the safety and preliminary effectiveness of the simplified hybrid frozen elephant trunk repair technique Branched Stented Anastamosis Frozen Elephant Trunk Repair (B-SAFER) which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments. The study will also evaluate the device functionality when using this operative technique for device implantation including multiple components. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04747626
Study type Interventional
Source The Cleveland Clinic
Contact Eric Roselli, M. D.
Phone 216-444-0995
Email roselle@ccf.rg
Status Recruiting
Phase N/A
Start date March 25, 2021
Completion date December 31, 2027

See also
  Status Clinical Trial Phase
Completed NCT05582967 - The DAShED (Diagnosis of Aortic Syndrome in the ED) Study
Terminated NCT04116684 - Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients N/A
Completed NCT02086136 - Aortic Dissection Detection Risk Score Plus D-dimer in Suspected Acute Aortic Dissection
Recruiting NCT02201589 - Feasibility of Endovascular Repair Of Ascending Aortic Pathologies N/A
Recruiting NCT03948555 - Magnetic Resonance Imaging (MRI) for Aortic Dissection to Visualise Inflammation
Enrolling by invitation NCT05912608 - Optimal Strategy for Repair of Type A Acute Aortic Dissection
Recruiting NCT03707743 - Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (STABILISE)
Enrolling by invitation NCT00583817 - Endovascular Treatment of Thoracic Aortic Disease N/A
Recruiting NCT05073991 - Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
Not yet recruiting NCT02523300 - Glucocorticoid on the Prognosis of TEVAR N/A
Completed NCT01197651 - Aortic-Stent-Register N/A
Recruiting NCT04471909 - NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness N/A
Not yet recruiting NCT06044259 - Study Comparing Hemiarch Replacement and Hemiarch Plus Stent Implantation in Acute Aortic Dissection N/A
Completed NCT05039814 - Prediction of Postoperative Acute Kidney Injury in Patients With Acute Type A Aortic Dissection Using Cystatin C
Recruiting NCT03780738 - A Validation Study of The Relationship Between ALDH2 and Aortic Dissection
Completed NCT03647566 - 18F Sodium Fluoride PET/CT in Acute Aortic Syndrome
Enrolling by invitation NCT05800743 - Evaluation of the GORE® Ascending Stent Graft N/A
Recruiting NCT03347812 - Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair N/A
Completed NCT05044494 - Surgery for Delay-recognized or Defer-operated Type A Aortic Dissection
Terminated NCT02958098 - My Research Legacy Pilot Study