Laser In Situ Fenestration Study

Launched by JONATHAN BATH · May 10, 2024

Keywords

ClinConnect Summary

The Laser In Situ Fenestration Study is a clinical trial testing a new device called the LIFE device, designed to treat aortic aneurysms, which are dangerous swellings in the main blood vessel that carries blood from the heart. The trial aims to find out if the LIFE device is effective and what health issues might arise when using it. If you or a loved one has an aortic aneurysm that is larger than 5.5 cm in men or 5.0 cm in women, or if there is a rapid growth that puts someone at high risk of rupture, you might be eligible to participate in this study. Other factors like previous surgeries or certain health conditions may also determine eligibility.

Participants in the trial will receive treatment with the LIFE device and will be monitored over several years, with check-ups at 30 days, 6 months, and up to 5 years afterward. These check-ups will include tests to assess kidney function and imaging scans of the aneurysm area. It’s important for potential participants to be aware that they need to be willing to travel to specific sites for the study and to commit to regular follow-ups. This trial is currently recruiting participants, and those interested will need to provide written consent to join.

Gender

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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.