After years of relative neglect, compared with the attention given to aortic disease, studies and devices designed to expand and improve treatment of peripheral arterial disease are moving to the forefront.
At this year’s VIVA Vascular meeting, the majority of late-breaking clinical trials have a focus on peripheral arterial disease (PAD) and critical limb ischemia (CLI), emphasizing the tremendous growth of research in this area. The following are some of the latest trials for which results will be presented:
On Monday morning, Michael P. Murphy, MD, will present results from the MOBILE clinical trial, which examines the use of the MarrowStim™ PAD Kit for the treatment of CLI in subjects with severe PAD. The treatment involves removing bone marrow from the hips, which is then processed in the MarrowStim device to separate stem cells for delivery by injection to multiple sites in the affected leg.
A report on the 6-month results from the two-phase DISRUPT PAD study to assess the safety and performance of the Shockwave Lithoplasty® System in treating calcified peripheral vascular lesions will then be presented by Thomas Zeller, MD, principal investigator for the study. “Lithoplasty is a novel technology utilizing integrated lithotripsy emitters that generate mechanical pulse waves to disrupt both superficial and deep calcium normalizing vessel wall compliance prior to low-pressure balloon dilatation,” according to a company report.
In addition, results from the IN.PACT SFA randomized trial will be presented by Prakash Krishnan, MD, and data from the VIRTUS US Iliofemoral Stenting IDE Trial will be addressed by Stephen Black, MD, and Michael R. Jaff, DO, will present insights on the use of drug-coated balloon treatment for patients with intermittent claudication based on results from the IN.PACT Global full clinical cohort.
On Tuesday morning, Stefan Müller-Hülsbeck, MD, will present the 2-year results plus subgroup analysis of the Majestic Trial, which examined the efficacy benefit of using the Eluvia drug-eluting stent for treating lesions in the femoropopliteal arteries.
This will be followed by Antonio Micari, MD, PhD, who will present the 2-year results of from the SFA-Long Study, which examines the use of paclitaxel coated balloons for long femoropopliteal artery disease.
On Wednesday morning, the 3-Year Results of the Evaluation of the ESPRIT Bioresorbable Vascular Scaffold (ESPRIT BVS) in The Treatment of Patients with Occlusive Vascular Disease of the Superficial Femoral (SFA) or Common or External Iliac Arteries (ESPRIT I Trial) will be presented by Michael R. Jaff, DO.
This will be followed by a presentation of the 12-month results from the DANCE Trial Atherectomy Cohort by Chris D. Owens, MD, and John Laird, MD, discussing the 9-month results of the Prospective, Multicenter BOLSTER Trial, which examined the use of an expanded polytetrafluoroethylene balloon-expandable covered stent for obstructive lesions in the iliac artery.
In further research addressing the peripheral vascular system, Dr. Laird will also address the 24-month results from the TIGRIS randomized trial, assessing the use of a novel nitinol stent for long lesions in the SFA and the proximal popliteal artery.
Afterwards, Richard Saxon, MD, will discuss the PRISM Indigo Aspiration System as a potential frontline tool for vacuum-assisted aspiration thrombectomy in the periphery.