Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms

NCT04526938 | Suspended DMC FDA Device

• 1 other identifier: FEVAR
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.

Conditions

Juxtarenal Aortic Aneurysm; Suprarenal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm

Keywords

Complex Aortic Aneurysm; Complex Abdominal Aortic Aneurysm; Aneurysm

Outcome Measures

Primary Outcomes (3)

• Freedom from Major Adverse Events (MAE) at 30 days

  Major Adverse Events include: Death, Bowel Ischemia, myocardial infarction, paraplegia/paraparesis, renal failure, respiratory failure, and stroke

  30 days

• Proportion of study subjects with treatment success at 1 year

  Treatment success is defined as a composite of technical success and freedom from the following: * Aneurysm enlargement \[i.e., \>5mm) as compared to a preoperative CT measure using orthogonal (i.e, perpendicular to the centerline) measurements\] * Aneurysm rupture * Aneurysm-related mortality * Conversion to open repair * Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events)

  1 year

• Technical success

  Technical success is defined as: * Successful delivery (i.e., ability to deliver the implant to the intended implantation site, without the need for unanticipated corrective intervention related to delivery) and deployment of the device at the intended location, * Patency of all endovascular graft and branch stent components * Absence of device deformations requiring unplanned placement of an additional device * Absence of inadvertent covering of aortic branch vessels * Successful withdrawal (i.e., successful withdrawal of the delivery system, without need for unanticipated corrective intervention related to withdrawal)

  1 year

Secondary Outcomes (1)

• Quality of Life measures

  30 days, 6 months; 1, 2, 3, 4 and 5 years

Study Arms (1)

Endovascular repair

EXPERIMENTAL

Endovascular repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms including those secondary to aortic dissection using a physician-modified endovascular graft.

Device: Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft

Interventions

Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft DEVICE

Cook Zenith® Alpha Thoracic Endovascular Graft will be modified to allow for the maintenance of blood flow into the visceral and renal branch vessels.

Endovascular repair

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
• Life expectancy \> 2 year(s)
• Patient is considered to be at high risk of morbidity and mortality with open surgical repair
• A patient may be entered into the study if the patient has at least one of the following:
• Juxtarenal, suprarenal or a thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter
• Aneurysm with a history of growth ≥ 0.5 cm per year
• Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation
• Symptomatic juxtarenal, suprarenal or a thoracoabdominal aortic aneurysm
• Thoracoabdominal aortic aneurysms secondary to aortic dissection meeting above criteria
• Patient is considered to be at high risk of morbidity and mortality with open surgical repair
• Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
• Nonaneurysmal aortic segment proximal to the aneurysm (neck) with a:
• Minimum neck length of 20mm
• Diameter in the range of 21-38mm
• Angle less than 60° relative to the axis of the aneurysm

You may not qualify if:

• Under the age of 18 years
• Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
• Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
• Willing to participate in a sponsor-investigator IDE with access to a non-physician modified endovascular prostheses at the investigational site
• Willing to travel to an investigational site with access to a non-physician modified endovascular prosthesis
• Unwilling or unable to comply with the follow-up schedule
• Inability or refusal to give informed consent by patient or legal representative
• Patient is pregnant or breastfeeding
• Free rupture with hemodynamic instability
• Ongoing infection
• Diagnosis of, or suspected connective tissue disease
• Known sensitivities or allergies to the materials of construction of the devices
• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Javairiah Fatima, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 26, 2020
• Study Start: September 20, 2021
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-01

Locations

US (1)