NCT06332911 Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
| NCT ID | NCT06332911 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rede Optimus Hospitalar SA |
| Condition | Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-05-19 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Marc Bosiers, Dr.
STUDY DIRECTOR
Rede Optimus Hospitalar AG
Frequently Asked Questions
Who can join the NCT06332911 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06332911 currently recruiting?
Yes, NCT06332911 is actively recruiting participants. Contact the research team at phina.muna@redeoptimus.com for enrollment information.
Where is the NCT06332911 trial being conducted?
This trial is being conducted at Münich, Germany, Nuremberg, Germany, Genoa, Italy, Verona, Italy and 1 additional location.
Who is sponsoring the NCT06332911 clinical trial?
NCT06332911 is sponsored by Rede Optimus Hospitalar SA. The principal investigator is Marc Bosiers, Dr. at Rede Optimus Hospitalar AG. The trial plans to enroll 30 participants.