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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05531084
Other study ID # 1861968
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date October 1, 2032

Study information

Verified date October 2022
Source Minneapolis Heart Institute Foundation
Contact Jesse Manunga, MD, FSVS, FACS
Phone 612-863-6800
Email jesse.manunga@allina.com
Is FDA regulated No
Health authority
Study type Interventional

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).


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).


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Study Design


Intervention

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.

Locations

Country Name City State
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Jesse Manunga, MD Minneapolis Heart Institute Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevention of aortic aneurysm related mortality and all cause mortality post intervention Primary outcome criteria:
Mortality related to primary aortic disease and intervention
All-cause mortality post intervention
5 years
Secondary Issues associated with disease progression, branched instability, endoleak and other disabling complications as evaluated on post-operative follow up and radiographic images. Secondary outcome criteria (as evidenced on follow up imaging and laboratory tests):
Evidence of aortic disease progression (aneurysm growth >/=5 mm)
5 years
Secondary Endoleak presence of any endoleak requiring intervention 5 years
Secondary Target vessels instability resulting in adverse events to the patient mesenteric ischemia
renal failure
5 years
Secondary procedure related complication stroke
Myocardial infarction
Paraplegia
5 years
Secondary Issues associated with device migration and failure - Device failure (migration >/=10 mm) years
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