August 7, 2020
iD3 Medical Commences SUPERSURG Study of Abbott’s Supera Stent in Common Femoral Artery Disease
August 8, 2020—Belgium-based iD3 Medical announced that the first two patients were enrolled in the physician-initiated, prospective, multicenter, randomized SUPERSURG study investigating the safety and efficacy of the Supera peripheral stent system (Abbott) versus surgical endarterectomy in treating patients with common femoral artery disease (with and without femoral bifurcation involvement).
According to iD3 Medical, the SUPERSURG study is planned to enroll 286 patients at 13 centers in four European countries (Belgium, Poland, the Netherlands, and the United Kingdom). First, patients will be stratified based on three criteria (obesity, calcification, and femoral bifurcation involvement). Then, consented patients will be randomized 1:1 to an open surgical arm or an endovascular arm.
In addition to primary endpoints of superior safety and noninferior efficacy of the Supera device arm, the study will assess core-lab–based angiographic outcomes after common femoral endarterectomy in a subcohort of 40 patients.
Koen Deloose, MD, principal investigator of the SUPERSURG study, performed the procedures on the first two patients in the trial: one patient was treated by open surgery and one was treated by an endovascular procedure with Supera. Dr. Deloose is Head of the Department of Vascular Surgery at AZ Sint Blasius Hospital in Dendermonde, Belgium.
“My enthusiasm about the use of the Supera peripheral stent system in the common femoral area was initiated by some case experiences at high risk for surgery with great longer-term follow-up,” commented Dr. Deloose in iD3 Medical’s announcement. “Based on these findings, we have set up the physician-initiated, single-arm VMI-CFA trial.
“The 12- and 24-month outcomes of this 100-patient cohort, presented at VIVA 2019, confirmed our initial enthusiasm with core-lab–based primary patencies of 95% and 93%, respectively, and freedom from target lesion revascularization of 98% at 2 years. As these results were very close to our surgical data, but with lower complication rates, the idea for head-to-head randomization between both treatment strategies, with the same stringent assessment methods (which is rather exceptional in our vascular world) was born. With a support grant from Abbott Vascular, we were able to launch this exciting project.”
Dr. Deloose concluded, “Based on the outcome of this trial, I hope to be able to define subgroups of patients who are better treated with surgery, others with a minimally invasive Supera peripheral stent system implantation. I’m convinced that there will be a place for both complementary strategies in the vascular future.”