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Trials / Recruiting

RecruitingNCT06332911

Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

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

Status
Recruiting
Phase
—
Study type
Observational
Enrollment
30 (estimated)
Sponsor
Rede Optimus Hospitalar SA · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEShockwave™ Peripheral Intravascular Lithotripsy Balloon M5+Cracking-not-debulking technique (SHOCKWAVE IVL)

Timeline

Start date
2025-05-19
Primary completion
2026-05-30
Completion
2027-05-30
First posted
2024-03-27
Last updated
2025-05-23

Locations

5 sites across 3 countries: Germany, Italy, Switzerland

Source: ClinicalTrials.gov record NCT06332911. Inclusion in this directory is not an endorsement.