Drug-eluting vascular stent has patency rate of over 96%

The Majestic clinical trial assessing Boston Scientific’s Eluvia drug-eluting vascular stent system reflected a primary patency rate of more than 96%

These results represent the highest 12-month primary patency reported for an interventional treatment of femoropopliteal artery lesions among comparable trials. 

The Eluvia Stent System is a treatment option for patients with narrowing or blockages in the superficial femoral artery (SFA) or proximal popliteal artery (PPA) that is a result of peripheral artery disease (PAD).

The Majestic trial enrolled 57 patients across Europe, Australia and New Zealand with an average lesion length of 70.8 mm.

The trial included a high percentage of complex lesions with 46% of lesions classified as total occlusions and 65% identified as severely calcified. 

Results from the trial also included a low 12-month target lesion revascularisation (TLR) rate of 3.8% with no observed stent fractures and no amputations.  

Stefan Müller-Hülsbeck, principal investigator and chairman at Vascular Center Diako Flensburg, said: “Achieving a 96% primary patency rate at one year with low major adverse events is exceptional.

“In my opinion, the sustained release of paclitaxel enabled by this technology could represent a significant advancement in the treatment of patients with peripheral arterial disease.”