Boston Scientific's Eluvia Stent Shows 96% Primary Patency at 12 Months in MAJESTIC

September 29, 2015—Boston Scientific Corporation announced new 12-month clinical trial outcomes from the MAJESTIC trial, which is assessing the safety and performance of the company’s Eluvia drug-eluting vascular stent system for the interventional treatment of femoropopliteal artery lesions. Results from the MAJESTIC trial were presented at CIRSE 2015, the Cardiovascular and Interventional Radiological Society of Europe annual scientific meeting being held September 26–30 in Lisbon, Portugal.

According to the company, the data demonstrate a primary patency rate of more than 96% and a 12-month target lesion revascularization rate of 3.8%, with no observed stent fractures and no amputations. 

MAJESTIC is a single-arm, multicenter, prospective study that enrolled 57 patients with 57 lesions, which were a mean 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.  The trial was conducted in Europe, Australia, and New Zealand under the leadership of Principal Investigator Prof. Stefan Müller-Hülsbeck, MD. 

In the company’s press release, Prof. Müller-Hülsbeck stated, “Achieving a 96% primary patency rate at 1 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.” Prof. Müller-Hülsbeck is Chairman of the Vascular Center Diako Flensburg and Head of the Department of Diagnostic and Interventional Radiology/Neuroradiology, Academic Hospitals Flensburg in Germany. 

Boston Scientific also announced at CIRSE that it has received an investigational device exemption from the US Food and Drug Administration to begin a global, pivotal study of the Eluvia stent system. The study, named the IMPERIAL trial, is designed to support future regulatory submissions, and patient enrollment is expected to begin in the coming months. 

IMPERIAL’s global primary investigator is William A. Gray, MD, who is  Director of Endovascular Services at Columbia University Hospital in New York, New York. Prof. Müller-Hülsbeck is the study’s European primary investigator.

At CIRSE 2015, Dr. Gray presented the study design for IMPERIAL. Dr. Gray advised that IMPERIAL is a prospective randomized controlled trial that will enroll 465 patients at up to 75 centers in the United States, Canada, New Zealand, Belgium, Germany, Austria, and Japan.

The single-blind noninferiority study will randomize patients 2:1 to treatment with the Eluvia paclitaxel-eluting stent system versus the Zilver PTX paclitaxel-eluting stent system (Cook Medical).

IMPERIAL’s primary efficacy endpoint is primary vessel patency as assessed by duplex ultrasound at 12 months postprocedure and adjudicated by an independent core laboratory. The primary safety endpoint is the rate of major adverse events, defined as all-cause death through 1 month, target limb major amputation through 12 months, and target lesion revascularization through 12 months, reported Dr. Gray.

Boston Scientific stated that the Eluvia stent system is specifically designed for deployment in the superficial femoral artery utilizing the antirestenotic drug paclitaxel in conjunction with a polymer. The Eluvia stent system is built on the company’s Innova stent system platform, consisting of a self-expanding nitinol stent and an advanced 6-F, low-profile, triaxial delivery system for added support and placement accuracy. The stent architecture features a closed-cell design at each end of the stent for more predictable deployment and an open-cell design along the stent body for improved flexibility, strength, and fracture resistance.

The Eluvia stent system is pending European CE Mark approval. In the United States, the Eluvia stent system is an investigational device and is not available for sale. Boston Scientific advised that data from the MAJESTIC trial are expected to support global regulatory submissions, advised the company.