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The objective of the study is to evaluate the safety and performance of Relay Pro and Relay NBS Pro devices in humans having thoracic aortic pathologies.
Clinical results will be used to apply for the CE certification.
This is a prospective, multicenter, non-randomized, single arm clinical study in patients presenting thoracic aortic pathologies. Patients with thoracic aortic pathologies who are planned to undergo thoracic endovascular aortic repair (TEVAR) with a stent-graft based on routine clinical assessments performed as part of the patients' standard care will be screened after obtaining the informed consent from the patients, and if eligible, enrolled and scheduled for the implantation procedure with the study device.
Following a baseline assessment, the implantation procedure will be performed according to the Instructions for Use and local routine practice. A follow-up visit will be performed 30 days after the implantation procedure. The investigator will perform assessments of the implantation procedure and device system and document adverse events and device deficiencies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relay Pro Device | Experimental | The Relay Pro thoracic stent-graft will be used to treat pathologies eligible for thoracic endovascular aortic repair (TEVAR). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic Endovascular Aortic Repair (TEVAR) | Device | thoracic endovascular repair (TEVAR) with a thoracic stent-graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from aneurysm or dissection-related mortality | All deaths due to the treated pathology, including aneurysm rupture, complications of TEVAR leading to new aortic pathology (e.g., retrograde dissection leading to fatal cardiac tamponade). | 30 days or less |
| Delivery and deployment success evaluation | Success will be based on the Delivery system evaluation, overall rate of vascular access complications
will be analyzed descriptively. | 30 days or less |
| Measure | Description | Time Frame |
|---|---|---|
| Major device-related adverse events (MAE) | MAEs include:
| 30 days after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
Patients who meet one or more of the following criteria are not eligible:
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| Name | Affiliation | Role |
|---|---|---|
| Vicenç Riambau | Thorax Institute Hospital ClÃnic de Barcelona | Principal Investigator |
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Relay Pro and Relay NBS Pro device
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| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |
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