Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+
DeviceCracking-not-debulking technique (SHOCKWAVE IVL)
NCT Number: NCT06332911
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Department of Vascular Surgery, LMU Hospital Munich, Münich, Bavaria, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cracking-not-debulking technique (SHOCKWAVE IVL)
Time frame: 30 days
Contact information is provided by the study sponsor or research team.
Annelena Held-Wehmöller, Dr.
CONTACT
Phina Muna, Dr.
CONTACT
Rede Optimus Hospitalar SA
Network
International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Acronym: TEVAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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