ID3 Medical Belgium has announced the first two enrollments in the SUPERSURG study to investigate the safety and efficacy of Abbotts’ Supera peripheral stent system versus surgical endarterectomy in treating patients with common femoral artery disease, with and without femoral bifurcation involvement.
The physician initiated, prospective, multicenter, randomized study is set to enroll 286 patients at 13 centers in four European countries (Belgium, Poland, the Netherlands, and the UK).
Patients will be stratified first based on three criteria: obesity, calcification, and femoral bifurcation involvement. After this stratification, consented patients will be 1:1 randomized in an open surgical or endovascular arm.
In addition to superior safety and non-inferior efficacy of the Supera peripheral stent system arm as primary endpoints, the study will also assess core lab-based angiographical outcomes post common femoral endarterectomy in a subcohort of 40 patients.
The principal investigator of the SUPERSURG study is Koen Deloose, MD, head of the department of vascular surgery at AZ Sint Blasius hospital in Dendermonde, Belgium, who performed the first two procedures (one open and one endo) in the trial.
“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,” comments Deloose in ID3 Medical’s announcement.
“Based on these findings, we set up the physician-initiated single-arm VMI-CFA trial,” Deloose continues. “The 12- and 24-months 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 (TLR) of 98% at two years (in press).
“As these results were very close to our surgical data, but with lower complication rates, the idea for a head-to-head randomization between both treatment strategies, with the same stringent assessment methods was born. With a support grant from Abbott Vascular, we were able to launch this exciting project.”
Looking to the future, Deloose concludes: “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 minimal invasive Supera peripheral stent system implantation. I am convinced that there will be a place for both complementary strategies in the vascular future.”