Using Shockwave technology for aortic repair procedures
International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Rede Optimus Hospitalar SA · NCT06332911
This study is testing if a new shockwave technology can help doctors successfully access tricky blood vessels during aortic repair surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rede Optimus Hospitalar SA (network) |
| Locations | 5 sites (Münich, Bavaria and 4 other locations) |
| Trial ID | NCT06332911 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon in treating challenging iliac access during thoracic and thoraco-abdominal aortic repairs. It involves collecting standardized data on procedures, underlying conditions, and cardiovascular risks, along with physiological parameters measured before, during, and after surgery. Follow-up visits at 1 month, 6 months, and 12 months will assess adverse events and the success of the procedures. The study aims to analyze the technical success of accessing hostile iliac vessels using this innovative technology.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with specific types of thoracic or thoraco-abdominal aneurysms requiring endograft implantation and facing hostile iliac access.
Not a fit: Patients without hostile iliac access or those not requiring thoracic or thoraco-abdominal aortic repairs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve access for complex aortic repairs, potentially leading to better patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving access for complex vascular procedures.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Münich, Bavaria and 4 other locations
- Department of Vascular Surgery, LMU Hospital Munich — Münich, Bavaria, Germany (RECRUITING)
- Department of Vascular Surgery, Klinikum Nürnberg Campus Süd — Nuremberg, Bavaria, Germany (RECRUITING)
- University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM — Genoa, Liguria, Italy (RECRUITING)
- Azienda Ospedaliera Universitaria Integrata di Verona — Verona, Veneto, Italy (RECRUITING)
- Inselspital, University Hospital Bern, Heart Vascular Center — Bern, Canton Bern, Switzerland (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Nikolaos Tsilimparis, Prof. — Department of Vascular Surgery, LMU Hospital Munich
- Study coordinator: Phina Muna, Dr.
- Email: phina.muna@redeoptimus.com
- Phone: +49 157 80 58 5869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, Abdominal Aortic Aneurysm Without Rupture, Thoracic Aortic Aneurysm Without Rupture