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

NCT05531084 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 1861968
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

surgeon-modified fenestrated stent grafts

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Issues associated with disease progression, branched instability, endoleak and other disabling complications as evaluated on post-operative follow up and radiographic images.

  5 years

• Endoleak

  5 years

• Target vessels instability resulting in adverse events to the patient

  5 years

• procedure related complication

  5 years

• Issues associated with device migration and failure

  years

Study Arms (2)

Thoracoabdominal aortic aneurysm extent I-III

EXPERIMENTAL

Thoracoabdominal aortic aneurysm extent I-III (proximal seal can be from the left carotid artery to directly after the left subclavian artery):

Device: Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)

Failed EVAR

EXPERIMENTAL

Failed EVAR (defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss)/juxtarenal/Pararenal/paravisceral/thoracoabdominal aortic aneurysm extent IV-V:

Device: Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)

Interventions

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

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.

Also known as: Cook Zenith Alpha Thoracic Endovascular Graft (P140016), Cook Zenith Fenestrated AAA Endovascular Graft (P020018 S044), Cook Zenith TX2 Dissection Endovascular Graft (P180001), Cook Zenith Flex AAA Bifurcated Main Body (P020018 S055), Atrium iCAST covered Stent (K050814), Gore Viabahn VBX Balloon Expandable Endoprosthesis (P160021)

Failed EVAR; Thoracoabdominal aortic aneurysm extent I-III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 18 years old
• The subject has one or more of the following:
• \. An aneurysm with a maximum diameter of \> 5.5 cm (in men) and 5 cm (in women) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e, perpendicular to the centerline) measurements 2. Aneurysm with a history of growth \> 0.5 cm in 6 months or clinically indicated for repair based on symptoms 3. Symptomatic aneurysm 4. Ruptured aneurysm 6. Failed previous EVAR defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss 7. Saccular aneurysm deemed by the treating vascular specialist at significant risk for rupture 8. High risk for open surgical repair based on any of the factors below:
• a. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery b. Physiological high risk For this IDE, physiological risk will be assessed using two systems. First, this study will use the Society for Vascular Surgery (SVS)/American Association for Vascular Surgery (AAVS) medical comorbidity grading system recommended for use by the SVS to describe the severity of medical comorbidities in patients with complex aortic aneurysm disease. However, as the current SVS/AAVS grading system has yet to be validated in prospective studies or in a large cohort of patients treated for aortic disease, the American Association of Anesthesiologists grading system will also be utilized due to its widely adopted use and simplicity although it relies on subjective parameters and lacks specific metrics that affect outcomes.
• Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical conduit
• Extent of aorta to be treated: infrarenal aortic aneurysms with \< 10 mm neck length, juxtarenal or pararenal aneurysms that include 1 or 2 renal arteries; paravisceral and extent IV-V thoracoabdominal aneurysms, Extent I-III thoracoabdominal aneurysm including those patients requiring a carotid-left subclavian bypass in order to achieve, at least, 20 mm of proximal landing zone
• Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a:
• Minimum neck length of 20 mm
• Diameter in the range of 20 mm - 38 mm
• Angle less than 60 degrees relative to the axis of the aneurysm
• Angle less than 60 degrees relative to the axis of the suprarenal aorta
• Minimum branch vessel diameter of 5 mm or greater Iliac artery distal fixation site greater than 45 mm in length and diameter in the range of 8 mm to 17 mm

You may not qualify if:

• Age: \< 18 years old
• Can be treated in accordance with the instructions for use with a commercially approved and marketed endovascular prosthesis
• Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site with the exception of percutaneous aortic valve surgery
• Unwilling or unable to comply with the follow-up schedule
• Inability or unwillingness of patient or patient's legally authorized representative to provide informed consent.
• Subject is pregnant or breastfeeding
• Known sensitivities or allergies to the materials of construction of the devices, including but not limited to titanium and PTFE.
• Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
• Uncorrectable coagulopathy
• Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
• Subject has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair
• Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest, or nocturnal angina)
• Systemic or local infection that may increase the risk of endovascular graft infection
• Baseline creatinine greater than 2.0 mg/dL
• Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access

Sponsors & Collaborators

• Jesse Manunga, MD: lead
• Minneapolis Heart Institute Foundation: collaborator

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Jesse Manunga, MD, FSVS, FACS

CONTACT

612-863-6800; jesse.manunga@allina.com

JoAnne Goldman

CONTACT

612-863-3833; joanne.goldman@allina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vascular and Endovascular Surgeon

Model Details: All participants will receive the same treatment modality (surgeon-modified fenestrated stent grafts).

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: September 7, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2032
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)