NCT05531084

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Jesse Manunga, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Thoracoabdominal Aneurysm
• Juxtarenal Aortic Aneurysm
• Pararenal Aneurysm
• Aortic Aneurysm
• Failed Previous Infrarenal Repairs (Failed EVAR)

Interventions

Type	Name	Description
DEVICE	Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)	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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2027-10-01
• Completion: 2032-10-01
• First posted: 2022-09-07
• Last updated: 2022-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study