Positive preliminary safety results have been revealed from the Vascular Wrap paclitaxel-eluting mesh trial, the first-in-man study designed to evaluate the safety and performance of a novel and proprietary drug-loaded Vascular Wrap in the prevention of stenosis after peripheral bypass surgery. The trial is sponsored by Angiotech Pharmaceuticals. The Principal Investigator of the trial is Dr Lindsey Machan, University of British Columbia, Vancover, Canada.
This study randomised patients with peripheral vascular disease in a 2:1 fashion. The treatment arm enrolled patients with a synthetic bypass graft plus the Vascular Wrap paclitaxel-eluting mesh and the control arm enrolled patients with a synthetic bypass graft alone. Preliminary safety assessment at six months indicated that the Vascular Wrap was safe in this high-risk patient population. Looking at events that could potentially be attributed to the use of the Vascular Wrap, no difference in safety was demonstrated between the two groups.
The Vascular Wrap is applied around the anastomosis site of a synthetic bypass graft and delivers drug to the blood vessel wall in a targeted manner to prevent or reduce the stenosis that typically follows this type of surgery. If successful, the Vascular Wrap could potentially be used in peripheral graft procedures to prolong the life of grafts and expand the possible application into other high demand indications with no real solutions, such as AV anastomosis used for dialysis. This single-blind, randomised study enrolled a total of 109 patients at nine clinical centres in Europe as well as the Dutch Antilles.