RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU) (RE-GENERATION)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03207568|
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : July 5, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Aorta, Thoracic Pathologies Aortic Aneurysm, Thoracic Aortic Aneurysm||Device: Thoracic Endovascular Aortic Repair (TEVAR)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Relay Pro and Relay NBS Pro device|
|Masking:||None (Open Label)|
|Official Title:||RE-GENERATION: An EU Clinical Study to Evaluate the Safety and Performance of the Relay Pro and Relay Non Bare Stent (NBS) Pro Stent-graft Devices in Patients With Thoracic Aortic Pathologies|
|Actual Study Start Date :||October 25, 2014|
|Actual Primary Completion Date :||April 14, 2016|
|Actual Study Completion Date :||April 30, 2016|
Experimental: Relay Pro Device
The Relay Pro thoracic stent-graft will be used to treat pathologies eligible for thoracic endovascular aortic repair (TEVAR).
Device: Thoracic Endovascular Aortic Repair (TEVAR)
thoracic endovascular repair (TEVAR) with a thoracic stent-graft
- Freedom from aneurysm or dissection-related mortality [ Time Frame: 30 days or less ]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).
- Delivery and deployment success evaluation [ Time Frame: 30 days or less ]
Success will be based on the Delivery system evaluation, overall rate of vascular access complications
- Rate of access failures
- Rate of deployment system difficulties
will be analyzed descriptively.
- Major device-related adverse events (MAE) [ Time Frame: 30 days after the procedure ]
- Endoleak (types I, Ill and IV)
- Stent migration (>10 mm)2
- Lumen occlusion
- Aorta rupture
- Conversion to open repair
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207568
|Principal Investigator:||Vicenç Riambau||Thorax Institute Hospital Clínic de Barcelona|