Clinical Trials Logo
  1. Home
  2. Aortic Aneurysm
  3. NCT05531084

Safety and Effectiveness of Surgeon-Modified Stent Grafts forTreatment of Complex Aortic Aneurysms — Assets  

Aortic Aneurysm Clinical Trial

Official title:
Safety and Effectiveness of Surgeon-Modified Fenestrated and Branched Endografts in Treating Subjects With Complex Aortic Aneurysms

Clinical Trial Summary

The primary objective of the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated stent grafts used to treat patients with failed previous infrarenal repairs (failed EVAR) and complex aortic aneurysms (thoracoabdominal, juxtarenal, pararenal, and paravisceral aneurysms).

Clinical Trial Description

The study is a prospective, non-randomized evaluation of endovascular repair of patients with failed previous infrarenal repairs (failed EVAR) and complex thoracoabdominal/juxtarenal/pararenal/paravisceral aortic aneurysm repair, including those with penetrating ulcers and aneurysms resulting from aortic dissections, who (1) have anatomy that is not suitable for endovascular repair using grafts currently marketed in the United States, (2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Depending on the location of the aneurysm, patients with failed EVAR and complex aortic pathology requiring fenestrated and branched endovascular repair will be treated with physician-modified Cook Zenith devices (Zenith Flex, Zenith Fenestrated stent graft (Zfen), Cook Alpha Thoracic Endovascular Graft, Cook dissection TX2), and their associated commercially approved ancillary components. Whenever possible, the Zenith fenestrated universal bifurcated device will be used for patients requiring repair down to the iliac arteries. The Gore Excluder Endoprosthesis or the Gore Iliac Branch Endoprosthesis (IBE) will be used whenever the Zenith universal bifurcated device is not available. Safety and effectiveness will be assessed acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)), at 6 months, at 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05531084
Study type Interventional
Source Minneapolis Heart Institute Foundation
Contact Jesse Manunga, MD, FSVS, FACS
Phone 612-863-6800
Email jesse.manunga@allina.com
Status Not yet recruiting
Phase N/A
Start date October 1, 2022
Completion date October 1, 2032
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04149600 - Identification of Genetic Causes of Calcific Aortic Valve Disease
Enrolling by invitation NCT04035356 - HAART Annuloplasty Device Valve Repair Registry
Recruiting NCT02729064 - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose Phase 1
Completed NCT02467062 - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease. N/A
Completed NCT02283307 - Dual Energy CT Urography With Reduced Iodinated Contrast N/A
Completed NCT01678261 - X-chromosome Inactivation, Epigenetics and the Transcriptome N/A
Terminated NCT01055275 - Cook Iliac Branch Graft Post-market Registry N/A
Completed NCT00615888 - Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair N/A
Completed NCT03510793 - Microcirculation and Anesthesia in Vascular Surgery
Completed NCT03207568 - RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU) N/A
Recruiting NCT05073991 - Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
Not yet recruiting NCT01918982 - Circulating Endothelial Progenitor Cells and Aortic Aneurysm N/A
Not yet recruiting NCT01918969 - Reference Values of Circulating Endothelial Progenitor Cells N/A
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Completed NCT01256372 - An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery Phase 2
Recruiting NCT00661518 - PET/CT Imaging of Aneurysm Wall Inflammation N/A
Completed NCT00094575 - Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA) Phase 4
Recruiting NCT04471909 - NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness N/A
Recruiting NCT05603520 - Phenotyping Heterogeneity and Regionality of the Aorta
Completed NCT03727542 - Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels N/A