Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Recruiting

• Conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture; Thoracic Aortic Aneurysm Without Rupture; Abdominal Aortic Aneurysm Without Rupture
• Interventions: Device: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+

• Registration Number: NCT06332911
• Lead Sponsor: Rede Optimus Hospitalar SA

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-27
• Status Verified: 2025-05
• Study Start: 2025-05-19
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-05-30
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
complex endovascular thoracic aortic repair	Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+	Patients submitted to complex endovascular thoracic aortic repair with hostile iliac access vessels using the Shockwave device to gain access.

Primary Outcome Measures

Name	Time	Method
Efficacy: Technical success - defined as intention-to-treat basis	30 days	* Successful dilatation of the access vessels to 8mm without rupture; * Successful endovascular access and deployment of all aortic devices; * Performance of the Shockwave™ IVL: Includes the definition for technical success as well as delivery of the intended main endograft without the need for surgical conversion, arterial rupture and iliac artery occlusion

Trial Locations

Locations (5)

Department of Vascular Surgery, LMU Hospital Munich; 🇩🇪 Münich, Bavaria, Germany

Department of Vascular Surgery, Klinikum Nürnberg Campus Süd; 🇩🇪 Nürnberg, Bavaria, Germany

University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM; 🇮🇹 Genova, Liguria, Italy

Azienda Ospedaliera Universitaria Integrata di Verona; 🇮🇹 Verona, Veneto, Italy

Inselspital, University Hospital Bern, Heart Vascular Center; 🇨🇭 Bern, Canton Bern, Switzerland