Safety & Effectiveness of Surgeon-Modified Stent Grafts forTreatment of

Status Not yet recruiting

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

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms