Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of the Nexusâ„¢ Aortic Arch Stent Graft System in patients that were implanted with the device as part of Compassionate Use Procedures.
The purpose of the study is to collect and analyze data that is recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use Procedures.The data will be used to obtain additional information on the safety and performance of the Nexusâ„¢ Aortic Arch Stent Graft System in patients affected by pathologies involving the aortic arch.
Data will be collected at each time point of patient's follow up conducted according to the standard of care in each site.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective data collection | Group includes subjects that were implanted with the Nexus device as part of compassionate use procedure before joining the CIP008 study. Only intervention foreseen by CIP008 study is retrospective collection of data previously recorded as standard of care in medical charts (refer to Intervention/treatment section) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrospective data collection | Other | Retrospective collection of data recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use duly authorized according to country specific regulations. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Evaluation Criteria | Device related mortality at 30 days post implantation based on review of medical charts by the Investigators | within 30 days post implantation |
| Performance Evaluation Criteria | Successful disease treatment at 30 days post implantation, defined as Stent Graft positioned in the aortic arch isolating the diseased lesion based on review of medical charts by the Investigators. | within 30 days post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Evaluation Criteria | Device related re-intervention (e.g. due to endoleak, stent graft occlusion, clinically significant migration) within 1 year from implantation and based on review of medical charts by the Investigators. | within 1 year post-implantation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-There are no exclusions. Data will be collected for all implanted population as described in the inclusion section above
Not provided
Not provided
Not provided
Not provided
Study population will include all patients that were implanted with the Nexus device as part of the compassionate use.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Filippo Neri | Rome | Lazio | 00135 | Italy | ||
| ADHB Charitable Trust |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000094626 | Aneurysm, Aortic Arch |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Auckland |
| New Zealand |
| Klinik Hirslanden | Zurich | CH-8032 | Switzerland |
| Zurich University Hospital | Zurich | CH-8091 | Switzerland |
| D002318 |
| Cardiovascular Diseases |
| D001018 | Aortic Diseases |