Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Launched by REDE OPTIMUS HOSPITALAR SA · Mar 20, 2024

Keywords

ClinConnect Summary

This clinical trial, called Shockwave TEVAR, is looking at a new treatment method for patients with certain types of aortic aneurysms, which are bulges in the aorta that can be dangerous if not treated. The study specifically focuses on using the Shockwave™ Peripheral Intravascular Lithotripsy Balloon to help improve access to blood vessels when performing a procedure called TEVAR (Thoracic Endovascular Aortic Repair). This is important when the blood vessels leading to the aorta are difficult to work with due to heavy calcification or narrowing.

To participate in the trial, you must be at least 18 years old and have a specific type of aortic aneurysm that requires a special type of graft. You also need to have challenging access in your iliac arteries, which are the large blood vessels in your pelvis. The trial is open to both men and women and will involve a procedure where the Shockwave device is used before inserting the main graft. Participants will be closely monitored to see how well this new approach works. It’s important to know that patients who have had certain previous surgeries or specific conditions may not be eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient (m/f) age ≥ 18 years at time of enrollment.
• • 2. Diagnosis of thoracic and/or thoraco-abdominal (Extent I-V) and juxta/para-renal/short-neck aneurysm requiring the implantation of a thoracic and/or thoraco-abdominal fenestrated/branched aortic endograft with delivery system introducer sheath diameter equal or larger than 18 Fr (6 mm).
• 3. Hostile iliac access was defined in the presence of:
• • Heavily circumferential calcified iliac arteries
• • Inner diameter ≤ 6 mm
• • Severe stenosis (\> 50%; \> 2.5 m/s peak velocity; absence of triphasic duplex signal in ipsilateral common femoral artery)
• 4. We will accept the following presentations of aneurysm:
• • urgent cases,
• • elective,
• • symptomatic
• • and fast growing.
• • 5. The repair was performed using Shockwave™ before the introduction of the main endograft. The iliac procedures can be accompanied by angioplasty and/or stent and stent-graft positioning.
• Exclusion Criteria:
• • 1. Patients submitted to surgical conduit bypass.
• • 2. Not-severely calcified disease (absence of calcification).
• • 3. In-stent restenosis/occlusion.
• • 4. Inability to cross with 0.014 guidewire.
• • 5. Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study.
• • 6. Pre-stented iliac access vessels at the level of Shockwave implementation.