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| Name | Class |
|---|---|
| Qmed Consulting A/S | INDUSTRY |
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The goal of this prospective, interventional, multicentre, single-arm performance objective study is to evaluate efficacy and safety of Cratosâ„¢ Branch Stent Graft System in treatment of lesions (dissection, IMH and PAU in descending aorta. The main question[s] it aims to answer are:
30-day all-cause Mortality rate
Composite of the following events from the time of enrolment through 12-month:
Participants will come for hospital office visits 1, 6, 12, 24-, 36-, 48- and 60-months post-procedure for the following, but not limited to assessments:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEVAR | Experimental | Thoracic Endovascular Repair (TEVAR) provides a minimally invasive treatment option for descending thoracic aorta (DTA) pathologies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cratosâ„¢ Stent Graft | Device | Cratosâ„¢ Stent Graft TEVAR procedure for the treatment of aortic lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All-cause mortality | 30-day |
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Inclusion Criteria:
Presence of thoracic aortic pathology (Dissection, including IMH and ULP; and PAU) deemed to warrant surgical repair which requires proximal graft placement in Zone 2
Age ≥18 years at time of informed consent signature
Informed Consent Form (ICF) is signed by Subject or legal representative
Must have appropriate proximal aortic landing zone, defined as:
Must have appropriate LSA landing zone, defined as:
Must have appropriate distal aortic landing zone, defined as:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Wang | Contact | 3105283618 | jing.wang@endovastec.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Zimmermann, Prof. Dr. | Universitätz Spital Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Recruiting | Zurich | Switzerland |
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| ID | Term |
|---|---|
| D000094667 | Penetrating Atherosclerotic Ulcer |
| ID | Term |
|---|---|
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |