Laser In Situ Fenestration Study

NCT ID: NCT06411990

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2031-06-30

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.

Detailed Description

In this clinical trial the LIFE device is used to treat people with aneurysms in the aorta near the kidney arteries (called juxtarenal or pararenal aortic aneurysms). Tubes, called stent grafts, are typically inserted through blood vessels in the groin and placed inside the aorta in the abdomen and chest area (endovascularly placed) to cover the tear or leak in the aorta. The LIFE device covers the tear or leak and has side branches to let blood flow into the kidney, spleen, intestine, or liver arteries. Participants in this study are not candidates for endovascular devices approved for endovascular aorta repair to the juxtarenal or pararenal aorta, not candidates for open repair, not willing to travel to sites that have access to manufacturer-made endovascular devices, and patients for whom there are no favorable alternatives, for example, urgent, symptomatic, and emergency cases.

Conditions

Aortic Aneurysm; Endovascular Aneurysm Repair

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endovascular Aneurysm Repair

Fenestrated Endovascular Aneurysm Repair using the LIFE Device System

Group Type: EXPERIMENTAL

Fenestrated Endovascular Aneurysm Repair using the LIFE Device System

Intervention Type: DEVICE

Fenestrated Endovascular Aneurysm Repair

Interventions

Fenestrated Endovascular Aneurysm Repair using the LIFE Device System

Fenestrated Endovascular Aneurysm Repair

Intervention Type: DEVICE

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Endovascular aortic repair requiring coverage of renovisceral branches.

3. 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.

4. 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.

5. Distance ≥ 5 mm between top of graft fabric and renovisceral branch orifice.

6. 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.

7. Renovisceral diameter between 4 and 13 mm at the origin.

8. At the time of case planning, the patient's anatomy appears amenable to complete exclusion of the aneurysm with laser fenestration techniques.

9. Not willing or able to travel to sites that have access to manufacturer-made investigational endovascular devices.

10. Not a candidate for currently approved endovascular options.

11. 18 years or older.

12. 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.

13. Patient is able and willing to meet all study requirements, including participating in follow up evaluations and attending required assessment visits.

Exclusion Criteria

1. Known sensitivities or allergies to the materials of construction of the devices, including Nitinol, polyester, Platinum-Iridium, stainless steel, fluoropolymer, and heparin.

2. Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.

3. Uncorrectable coagulopathy.

4. Body habitus that would inhibit radiographic visualization of the aorta or exceeds the safe capacity of equipment.

5. Concurrent participation in another research protocol for investigation of an experimental therapy.

6. Subject has been judged to be unsuitable for participation in the study by the Investigator for any reason.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: collaborator

Jonathan Bath

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Bath

Associate Professor of Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jonathan Bath, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri School - Columbia

Locations

University of Missouri - Columbia

Columbia, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Randolph, Nurse, Clinical Research, RN, BSN

Role: CONTACT

randolphjl@health.missouri.edu

573-882-4387

Facility Contacts

Jonathan Bath, MD

Role: primary

bathj@health.missouri.edu

573-882-8743

Jennifer Randolph, RN, BSN

Role: backup

randolphjl@health.missouri.edu

(573) 882-4387

Other Identifiers

2023-001

Identifier Type: OTHER

Identifier Source: secondary_id

2102631

Identifier Type: -

Identifier Source: org_study_id