Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study.

OBJECTIVES: The purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB). BACKGROUND: DCB coatings differ in excipients, paclitaxel dose, and coating morphologies. Due to these differences, a class effect with DCBs has not been demonstrated. Consequently, each DCB needs to be evaluated independently based on its own clinical study results. METHODS: The ILLUMENATE Global Study is a prospective, multicenter, single-arm study. Patients with intermittent claudication or ischemic rest pain due to superficial femoral artery (SFA) and/or popliteal peripheral artery disease (PAD) were treated with the Stellarex DCB. The primary efficacy endpoint was primary patency, defined as freedom from restenosis with peak systolic velocity ratio ≤2.5 or clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety endpoint was freedom from device and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and CD-TLR through 12 months. RESULTS: In total, 417 lesions were treated in 371 patients. The mean lesion length was 7.5 ± 5.3 cm, 40.8% of lesions were severely calcified per core laboratory fluoroscopy criteria and 31.3% were total occlusions. Primary patency by independent duplex core lab evaluation was 81.4% and the freedom from CD-TLR was 94.8% day 365 per Kaplan-Meier estimate. The majority of patients experienced improvements in their Rutherford classification (90.3%) and walking impairment questionnaire score (83.6%) at 12 months compared to baseline. CONCLUSIONS: This study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes.

A laparoscopic endovascular aortobifemoral conduit that can be retained as a long-term bypass: a solution for patients with inadequate iliac access.

PURPOSE: To present a laparoscopic technique for placing a partially stented aortobifemoral (ABF) conduit that can be used for more proximal endovascular manipulations and then be retained as a permanent bypass of occlusive iliac disease. TECHNIQUE: Ethical approval was obtained to use a fresh frozen cadaver. The left common iliac artery, distal aorta, and proximal right common iliac artery were dissected laparoscopically. A curved hollow needle was inserted into the distal aorta, and wire access was obtained. A partially stented bifurcated Dacron bypass graft was deployed under fluoroscopic guidance into the distal aorta. The limbs of the bypass were then used as conduits for endovascular access before being tunneled behind the ureters and anastomosed to the femoral arteries in the usual way, retaining the stented graft as an ABF bypass. CONCLUSION: This novel technique combines laparoscopic access with endovascular manipulation to place an ABF conduit, which can be retained as a permanent bypass without the need for an abdominal incision. This technique could provide a minimally invasive solution for pelvic occlusive disease that hinders endovascular repairs, as well as a minimally invasive means of securing endoluminal access in patients with iliac arteries of inadequate caliber.