Aortic Aneurysm, Thoracic Clinical Trial
Official title:
Evaluation of the Vascutek Ltd. Thoracic Endovascular Stent Graft System (ThoraflexTM)in the Treatment of Aneurysm or Penetrating Ulcer of the Descending Thoracic Aorta
ThoraflexTM is designed for the treatment of aneurysm or penetrating ulcer of the descending
thoracic aorta. Each system is advanced from a transfemoral or transiliac approach over a
0.035" guidewire and positioned under fluoroscopic control. If necessary, an arterial
conduit technique may be required to allow access to the arterial system. The soft tapered
tip allows atraumatic insertion into the vessel, while the catheter and sheath are designed
to provide excellent flexibility and control through tortuous arterial anatomy.
Each individual stent graft device is supplied sterile and pre-loaded in a single-use
delivery system. The stent graft is a self-expanding endoprosthesis constructed of a thin
wall woven polyester and nitinol ring stents, which are attached to the fabric with braided
polyester sutures. The delivery system central catheter is a stainless steel braided
co-extrusion of polytetrafluoroethylene (PTFE) and polyester elastomer, designed to provide
significant torque control and strength, while also maintaining superior flexibility. The
outer sheath is made in a tri-layer construction consisting of a PTFE liner, a stainless
steel flat braid layer and a polyester elastomer outer jacket with a hydrophilic lubricant
coating. These materials provide very low friction force during device insertion and
deployment together with enhanced flexibility of the delivery system. The handle components
are moulded from thermoplastic polyurethane.
The materials of the endoprosthesis are identical to those of the current Conformité
Européenne (CE) marked Vascutek Ltd. AnacondaTM Stent Graft System intended for abdominal
aortic aneurysm repair. The materials of the delivery system are well established in medical
applications. The design of ThoraflexTM is based on the same principles as other clinically
established thoracic endovascular devices. The endoprosthesis is constructed of
self-expanding nitinol stents and a polyester tube graft. Four proximal hooks anchor the
endoprosthesis within the aorta. Unlike existing thoracic endovascular devices, the delivery
system of ThoraflexTM allows repositioning of the endoprosthesis so that the optimal
deployment position can be enhanced.
The intended use of ThoraflexTM is the treatment of aneurysm or penetrating ulcer of the
descending thoracic aorta, which is identical to other CE approved thoracic endovascular
devices.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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