Laser In Situ Fenestration Study

NCT06411990 | Recruiting DMC FDA Device

• 2 other identifiers: 21026312023-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about a new device, named the LIFE device, to treat people with aneurysms (swellings) in the aorta (large, main blood vessel that delivers blood from the heart to the body). The main questions this trial aims to answer are:

• If the LIFE device works to treat aortic aneurysms
• What medical problems participants have when the LIFE device is used Participants will undergo treatment with the LIFE device and thereafter at 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years have their pulses checked, bloodwork to check kidney function (BUN and serum creatinine), and a CT scan of the aneurysm area.

Conditions

Aortic Aneurysm; Endovascular Aneurysm Repair

Keywords

Fenestrated Endovascular Aneurysm Repair

Outcome Measures

Primary Outcomes (2)

• Number of participants with freedom from death and major adverse events (MAE)

  Number of subjects with freedom from all cause mortality and freedom from major adverse events. Major adverse events include myocardial infarction, chronic renal insufficiency / chronic renal failure requiring, dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilatory support.

  30 days

• Number of participants with device procedure technical success and freedom from endoleak, migration, aortic enlargement, aortic rupture, and aortic or branch-related reinterventions in

  Device technical success (at the end of index procedure) and freedom from Type I and III endoleak, device migration ≥ 10 mm, aortic enlargement ≥ 5 mm, aortic rupture, and aortic or branch-related reinterventions, including conversion to open repair (within 12 months of the index procedure)

  12 months

Secondary Outcomes (20)

• Number of participants with delivery and deployment of the LIFE Device System

  Procedure

• Number of participants with delivery and deployment of the thoracic/abdominal stent graft

  Procedure

• Number of participants with coverage of intended aneurysm

  Procedure

• Number of participants with contrast flow into target renovisceral vessels

  Procedure

• Estimated blood loss

  Procedure

Study Arms (1)

Endovascular Aneurysm Repair

EXPERIMENTAL

Fenestrated Endovascular Aneurysm Repair using the LIFE Device System

Device: Fenestrated Endovascular Aneurysm Repair using the LIFE Device System

Interventions

Fenestrated Endovascular Aneurysm Repair using the LIFE Device System DEVICE

Fenestrated Endovascular Aneurysm Repair

Also known as: Medtronic Valiant Thoracic Stent Graft with the Captive Delivery System, Medtronic Endurant II Stent Graft System, Medtronic Endurant IIs Stent Graft System and/or, Medtronic Endurant Aorto-uni-iliac (AUI) Stent Graft System, GORE VIABAHN VBX Balloon Expandable Endoprostheses, Spectranetics CVX-300 Excimer Laser System with the Spectranetics Turbo-Elite Laser Atherectomy Catheter

Endovascular Aneurysm Repair

Eligibility Criteria

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

You may qualify if:

• Aortic aneurysm \>5.5 cm in a man or \> 5.0 cm in a woman or rapid expansion deemed at significant risk for rupture in the juxtarenal or pararenal aorta.
• Endovascular aortic repair requiring coverage of renovisceral branches.
• Not candidate or at high risk for open repair. For example, but not exclusively, due to renal dysfunction, previous abdominal surgery, obese body habitus, previous coronary bypass grafts or high cardiac risk, chronic obstructive pulmonary disease (COPD) or on oxygen at rest, poorly controlled diabetes, current smoking, or antiplatelet or anticoagulation use.
• Proximal aortic landing zone in Zone 5 of the aorta or previous graft of at least 10 mm in length and diameter of between 20 and 40 mm.
• Distance ≥ 5 mm between top of graft fabric and renovisceral branch orifice.
• At least a 5 mm iliofemoral artery to accept the endovascular stent graft device and an axillary brachial artery of sufficient diameter to accept the laser catheter.
• Renovisceral diameter between 4 and 13 mm at the origin.
• Not willing or able to travel to sites that have access to manufacturer-made investigational endovascular devices.
• Not a candidate for currently approved endovascular options.
• years or older.
• Patient or legally authorized representative agrees to participate in the study and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
• Patient is able and willing to meet all study requirements, including participating in follow up evaluations and attending required assessment visits.

You may not qualify if:

• Known sensitivities or allergies to the materials of construction of the devices, including Nitinol, polyester, Platinum-Iridium, stainless steel, fluoropolymer, and heparin.
• Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.
• Uncorrectable coagulopathy.
• Body habitus that would inhibit radiographic visualization of the aorta or exceeds the safe capacity of equipment.
• Concurrent participation in another research protocol for investigation of an experimental therapy.
• Subject has been judged to be unsuitable for participation in the study by the Investigator for any reason.

Sponsors & Collaborators

• Jonathan Bath: lead
• University of Missouri-Columbia: collaborator

Study Sites (1)

University of Missouri - Columbia

Columbia, Missouri, 65212, United States

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Jonathan Bath, MD

  University of Missouri School - Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Randolph, Nurse, Clinical Research, RN, BSN

CONTACT

573-882-4387; randolphjl@health.missouri.edu

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: Associate Professor of Surgery

Model Details: Prospective, single arm clinical trial

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 14, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2031
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)