Medtronic has announced positive results at one-year follow-up of the Complete SE (self-expanding) vascular stent study for the treatment of atherosclerosis in the superficial femoral artery (SFA).
As presented for the first time at ISET and LINC in January, the Complete SE SFA study demonstrated a primary patency rate of 73.1%, a major adverse event rate of 11% and a target lesion revascularisation (TLR) rate of 9.4% at 12 months of patient follow-up. The TLR rate means that more than 90% of study subjects at one-year had not required another procedure to treat the target lesion.
The Complete SE SFA study was a prospective, single-arm trial that enrolled 196 subjects (with a total of 213 lesions) at 28 sites in the United States and Europe.
Approved by the US Food and Drug Administration (FDA) under an investigational device exemption (IDE), the study evaluated the safety and efficacy of the Complete SE stent in treating lesions of the SFA, including the proximal popliteal artery (PPA), with the primary endpoints assessed at 12 months: major adverse events for safety and primary patency for efficacy. All study subjects were determined to have symptomatic, ischaemic peripheral artery disease involving the superficial femoral artery and the proximal popliteal artery.
The principal investigators of the study are John Laird, UC Davis Medical Center, United States and Dierk Scheinert, University of Leipzig Heart Center, Germany.
“The strong performance of the Complete SE vascular stent in this rigorously conducted clinical trial is encouraging,” said Laird, who presented the results at this year’s International Symposium on Endovascular Therapy (ISET) in Miami, USA, and the Leipzig Interventional Course (LINC) in Germany. “The investigators found the device easy to use in treating superficial femoral artery lesions of varying complexity, which is indicative of clinical practice.”
Study subjects showed statistically significant improvements in all measures of clinical and functional effectiveness, such as Rutherford Category, mean ABI/TBI, and Walking Assessment.
These improvements were achieved despite the enrolment of patients with moderately or severely calcified lesions (91.0%), diabetes (45.4%), and a Rutherford Category rating of 3 or higher (66.8%) at baseline.
More than 80% of study subjects had achieved a Rutherford Category value of 0 or 1, the favorable end of the 0–6 scale, at 30 days, and that benefit persisted through six months and one year of follow-up. Treatment with the Complete SE stent also resulted in highly significant positive shifts in mean ABI/TBI scores at six and 12 months, with more than 60% of study subjects improving by at least 0.15 over the follow-up period. On Walking Assessment measures, impairment improved by 36.8%, distance by 32.4%, speed by 21.8% and stair climbing by 23.3%.
The Complete SE stent is commercially approved by the FDA for use in the iliac arteries. The company plans to seek FDA approval for the superficial femoral artery indication.