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A multicenter, prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.
The purpose of the study is to evaluate the safety and performance of the Nexusâ„¢ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic pathologies requiring landing in the Aortic Arch (zone 0, zone 1, zone 2).
The Nexusâ„¢ Aortic Arch Stent Graft System is indicated for the endovascular treatment of thoracic aortic pathologies involving the aortic arch (such as aneurisms and dissections). The Nexusâ„¢ is intended to exclude the lesion from the blood circulation in patients diagnosed with thoracic aortic pathology and who have appropriate anatomy to accommodate the Nexusâ„¢ system in an endovascular procedure.
The primary objectives of the study are to evaluate the safety and performance of the Nexusâ„¢ Aortic Arch Aneurysm Stent Graft System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic Aortic Disease Single Arm Study | Experimental | Thoracic Aortic Disease treated by Stent Graft Placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent Graft Placement (Nexus) | Device | The Nexus stent graft is introduced through a groin to the diseased location at the Aortic Arch. Depending on the patients anatomy and other medical considerations the physician may decide that blood flow to the sub-clavian artery and possibly also to the left carotid artery is required to be maintained via "surgical bypass grafting", either immediately, or a few days, before the implantation. In addition to the incision for introducing the investigational stent graft, two smaller access sites are required, one at the groin on the opposite side and on into the Right Arm to the Brachial Artery. This endovascular procedure will likely require full anesthesia. The entire procedure is assisted by an angiography imaging system. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Device related mortality at 30 days post implantation | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Device related re-intervention within 1 year from implantation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Performance: Assess the rate of successful disease treatment at 30 days post implantation | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Lachat, Prof. MD | Klinic Hirslanden, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Hospital Hradec Kralove | Hradec Králové | 500 05 | Czechia | |||
| San Filippo Neri Hospital |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 12, 2024 | |
| Reset | Nov 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 12, 2024 | Nov 14, 2024 |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Rome |
| 00135 |
| Italy |
| Klinic Hirslanden | Zurich | Witellikerstrasse 40 | CH-8032 | Switzerland |
| Zurich University Hospital | Zurich | 8091 | Switzerland |
| D001018 |
| Aortic Diseases |