RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices … (NCT03207568) | Clinical Trial Compass
CompletedNot Applicable
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
30 participantsStarted 2014-10-25
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Patient diagnosed with thoracic aorta pathology (aneurysm, pseudoaneurysm, dissection, penetrating ulcer or intramural hematoma) suitable for TEVAR with a Relay Pro or Relay NBS Pro stent-graft; diagnosis must be confirmed by contrast computed tomography angiography (CTA) or magnetic resonance imaging (MRI) within 3 months of the planned implant procedure.
* Proximal and distal aortic necks suitable for stent-graft placement (i.e., diameter ranging between 18 and 42 mm)
* Proximal and distal landing zones suitable for the stent-graft
* Adequate vascular access for insertion of the delivery system, i.e., femoral or iliac arteries a minimum 6 mm in diameter to accommodate the 19 to 22-Fr outer-diameter delivery system and no excessive disease precluding delivery system entry/passage or iliac arteries that could be extended via an access conduit.
* Written informed consent provided by the subject him/herself (not a representative) upon enrollment
Exclusion Criteria:
Patients who meet one or more of the following criteria are not eligible:
* Aneurysm/lesion location not accessible to the delivery system and stent placement
* Arterial access size insufficient for delivery system entrance or impossibility to perform a surgical access conduit
* Treatment of lesion that would require a delivery system with usable length greater than 90 cm
* Excessive arterial disease precluding delivery system entrance or passage
* Systemic infection
* Arterial tortuosity no…
What they're measuring
1
Freedom from aneurysm or dissection-related mortality