Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair (TEVAR)

Rede Optimus Hospitalar

Status: Enrolling

Conditions: Abdominal Aortic Aneurysm Without Rupture; Thoracic Aortic Aneurysm Without Rupture; Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture

Treatments: Device: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT06332911

RO-231129

Details and patient eligibility

About

Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.

The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR.

Full description

Standardized forms will collect data on the performed procedure, underlying pathology, cardiovascular risks and information on preoperative examinations. Physiological parameters routinely measured prior, during and after any surgical intervention will be recorded as well. A 1 month, 6-months and 12-months follow-up visit will be conducted to assess adverse events and outcome of the index procedure.

In addition, this study aims to analyze the technical and procedure success to gain access via hostile iliac access vessels withShockwave Peripheral Intravascular Lithotripsy Balloon in patients submitted for complex endovascualre thoracic, throaco-abdominal or abdominal aortic repair.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

complex endovascular thoracic aortic repair

Description:

Patients submitted to complex endovascular thoracic aortic repair with hostile iliac access vessels using the Shockwave device to gain access.

Treatment:

Device: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+