Thoracoabdominal Aortic Aneurysm, Without Mention of RuptureTEVARNCT06332911
Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
An observational study of Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture and Abdominal Aortic Aneurysm Without Rupture, run by Rede Optimus Hospitalar SA at 5 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, Abdominal Aortic Aneurysm Without Rupture, Thoracic Aortic Aneurysm Without Rupture
- What is being tested?
- Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 19 May 2025to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient (m/f) age ≥ 18 years
Who may be able to join
- Patient (m/f) age ≥ 18 years at time of enrollment.
- 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).
- 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)
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- We will accept the following presentations of aneurysm:
- urgent cases,
- elective,
- symptomatic
- and fast growing.
- 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.
Who cannot join
- Patients submitted to surgical conduit bypass.
- Not-severely calcified disease (absence of calcification).
- In-stent restenosis/occlusion.
- Inability to cross with 0.014 guidewire.
- Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study.
- Pre-stented iliac access vessels at the level of Shockwave implementation.
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
Germany2 sites, 2 recruiting
- Recruiting
Department of Vascular Surgery, LMU Hospital Munich
Münich, Bavaria, 80337
Prof. Nikolaos Tsilimparis, +49 (0)89 4400 73505, Nikolaos.Tsilimparis@med.uni-muenchen.de
- Recruiting
Department of Vascular Surgery, Klinikum Nürnberg Campus Süd
Nuremberg, Bavaria, 90471
Prof. Eric Verhoeven, +49 (0) 911 398-2651, eric.verhoeven@klinikum-nuernberg.de
Italy2 sites, 2 recruiting
- Recruiting
University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM
Genoa, Liguria, 16132
Prof. Giovanni Pratesi, +39 010 555 2424, giovanni.pratesi@hsanmartino.it
- Recruiting
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Veneto, 37126
Prof. Gian Franco Veraldi, +39-045-812-2505, gianfranco.veraldi@aovr.veneto.it
Switzerland1 site, 1 recruiting
- Not yet recruiting
Inselspital, University Hospital Bern, Heart Vascular Center
Bern, Canton Bern, CH-3010
Prof. Dr. Drosos Kotelis, +41(0)031 6325000, drosos.kotelis@insel.ch
About this study
Official title: International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
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.
Read the 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
- Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, Abdominal Aortic Aneurysm Without Rupture, Thoracic Aortic Aneurysm Without Rupture
- Being tested
- Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+Device
Cracking-not-debulking technique (SHOCKWAVE IVL)
| Study group | Role | What they receive |
|---|---|---|
| complex endovascular thoracic aortic repair | Patients submitted to complex endovascular thoracic aortic repair with hostile iliac access vessels using the Shockwave device to gain access. Receives: Device: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start19 May 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal Aortic Aneurysm, Without Mention of RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rede Optimus Hospitalar SA
- Sponsor type
- Research network
- Collaborators
- Shockwave Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- Marc Bosiers, Dr., Study director, Rede Optimus Hospitalar AGNikolaos Tsilimparis, Prof., Principal investigator, Department of Vascular Surgery, LMU Hospital Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332911
- Sponsor's protocol ID
- RO-231129
- Acronym
- TEVAR
- Status last verified
- May 2025
- First submitted
- 20 Mar 2024
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
- ClinicalTrials.gov ID
- NCT06332911
- Acronym / sponsor ID
- TEVAR / RO-231129
- Conditions
- Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, Abdominal Aortic Aneurysm Without Rupture, Thoracic Aortic Aneurysm Without Rupture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rede Optimus Hospitalar SAResearch network
- Collaborators
- Shockwave Medical, Inc.
- Study start
- 19 May 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| complex endovascular thoracic aortic repair | – | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient (m/f) age ≥ 18 years
Key inclusion criteria (12 listed)
- Patient (m/f) age ≥ 18 years at time of enrollment.
- 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).
- Hostile iliac access was defined in the presence of:
- We will accept the following presentations of aneurysm:
- 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.
Key exclusion criteria (6 listed)
- Patients submitted to surgical conduit bypass.
- Not-severely calcified disease (absence of calcification).
- In-stent restenosis/occlusion.
- Inability to cross with 0.014 guidewire.
- Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+Cracking-not-debulking technique (SHOCKWAVE IVL) | Device | complex endovascular thoracic aortic repair |
Primary outcome
Efficacy: Technical success - defined as intention-to-treat basis
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Bosiers, Dr. study director
Rede Optimus Hospitalar AG
Nikolaos Tsilimparis, Prof. principal investigator
Department of Vascular Surgery, LMU Hospital Munich
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture and Abdominal Aortic Aneurysm Without Rupture, run by Rede Optimus Hospitalar SA at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phina Muna, Dr. (+49 157 80 58 5869, phina.muna@redeoptimus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Technical success - defined as intention-to-treat basis (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.