Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Abdominal Aortic Aneurysm Without Rupture Clinical Trial

— TEVAR  

Official title:

International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06332911
• Other study ID #: RO-231129
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: August 30, 2026

Study information

• Verified date: March 2024
• Source: Rede Optimus Hospitalar SA
• Contact: Phina Muna, Dr.
• Phone: +49 157 80 58 5869
• Email: phina.muna[@]redeoptimus.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm Without Rupture
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracic
• Aortic Aneurysm, Thoracoabdominal
• Rupture
• Thoracic Aortic Aneurysm Without Rupture
• Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture

Intervention

Device:
• Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+
Cracking-not-debulking technique (SHOCKWAVE IVL)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rede Optimus Hospitalar SA	Shockwave Medical, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Technical success - defined as intention-to-treat basis	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	30 days