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| Name | Class |
|---|---|
| Shockwave Medical, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+ | Device | Cracking-not-debulking technique (SHOCKWAVE IVL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Technical success - defined as intention-to-treat basis |
| 30 days |
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Inclusion Criteria:
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.
Exclusion Criteria:
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Patient (m/f) age ≥ 18 years
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phina Muna, Dr. | Contact | +49 157 80 58 5869 | phina.muna@redeoptimus.com | |
| Annelena Held-Wehmöller, Dr. | Contact | +49 157 85128140 | annelena.held@redeoptimus.com |
| Name | Affiliation | Role |
|---|---|---|
| Marc Bosiers, Dr. | Rede Optimus Hospitalar AG | Study Director |
| Nikolaos Tsilimparis, Prof. | Department of Vascular Surgery, LMU Hospital Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Vascular Surgery, LMU Hospital Munich | Recruiting | Münich | Bavaria | 80337 | Germany |
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| Department of Vascular Surgery, Klinikum Nürnberg Campus Süd | Recruiting | Nuremberg | Bavaria | 90471 | Germany |
|
| University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM | Recruiting | Genoa | Liguria | 16132 | Italy |
|
| Azienda Ospedaliera Universitaria Integrata di Verona | Recruiting | Verona | Veneto | 37126 | Italy |
|
| Inselspital, University Hospital Bern, Heart Vascular Center | Not yet recruiting | Bern | Canton Bern | CH-3010 | Switzerland |
|
| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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