Vacuum-assisted Sclerotherapy Catheter Study on Velex for Endovascular-Nonthermal, Nontumescent Empty Vein Ablation: Preliminary Results of the World's First Clinical Trial

Report preliminary results from the vacuum-assisted sclerotherapy catheter (VASC) postmarket clinical follow-up study, a multicenter, prospective, nonrandomized trial with the primary objective to confirm safety and efficacy of the Velex (I-VASC S.r.l., Milan, Italy) empty vein ablation (EVA) system in the treatment of the great saphenous vein (GSV) (registered on ClinicalTrials.gov, ID: NCT05581524). Blood flow is considered a limitation for sclerotherapeutic and endovascular treatment of diseased veins. Velex is the first minimally invasive device for endovascular treatment of varicose veins by EVA—a nonthermal, nontumescent technique with good in vivo results in preclinical study. EVA consists of a chemical ablation with low polidocanol concentration, and full control of the contact time between drug and the venous wall. After inflating a long central balloon that removes the blood from the segment intended to treat, isolating it with two lateral balloons, and injecting the drug (simultaneously deflating the central balloon), the catheter can be pulled back to treat the entire length of the vein (Figure, A, B). In total, 24 to 36 patients affected by chronic venous insufficiency of the GSV will be enrolled in two participating centers. The primary endpoint is vein occlusion evaluated intraoperatively with duplex ultrasound examination at postoperative day 7, and at three months and six months. Minor and major adverse events will be recorded. The secondary endpoint is evaluation of pain score during the procedure. A quality-of-life questionnaire will be filled in preoperatively and at three-monthly visits for comparative analysis. Main exclusion criteria are GSV standing diameter of >12 mm for vein segments longer than 3 cm, or diameter of <4 mm for segments >5 cm. From June 14, 2022, eight patients (six female; mean age, 52 years) underwent EVA treatment of the GSV using Velex. Based on data confirmed and available at the time of abstract submission, maximum GSV diameter was 10.5 mm (mean, 8.1 mm). Notably, the GSV was completely occluded in the whole treated segment according to intraoperative duplex ultrasound control. A shrinkage of GSV diameter was observed at 7 days, 1 month, and 3 months (Table; Figure, C). Mean pain score was 3. No major adverse events occurred. Although these results are very preliminary, outcomes at 1 and 3 months suggest that Velex could be very effective for nonthermal, nontumescent endovascular treatment of superficial venous insufficiency by EVA.TableGSV diameter at duplex ultrasound examination performed at different levels of the thigh: Baseline, at postoperative day 7, and at the 1- and 3-month follow-upsParameterPatient 1 45 yearsPatient 2 73 yearsPatient 3 53 yearsPatient 4 32 yearsPatient 5 55 yearsPatient 6 65 yearsPatient 7 33 yearsPatient 8 63 yearsBaseline Proximal vein diameter5.57.576.56.86.46.88 Maximum caliber1010.58.577.27.579.7 Mid/distal-thigh vein diameter8.38.5977.46.85.67.1 Maximum caliber10109.87.48.97.1687-Day follow-up Mean proximal vein diameter56.5 Mean mid/distal-thigh vein diameter47 Complete closureYesYesaaaaa1-Month follow-up Mean proximal vein diameter56.7 Mean mid/distal-thigh vein diameter4.56.1 Complete closureYesYesaaaaa3-Month follow-up Mean proximal vein diameter3.34.7 Mean mid/distal-thigh vein diameter3.54.7 Complete closureYes, slight reperfusion of 4 cm of GSV at proximal thigh, but without refluxYes, slight reperfusion of 5 cm of GSV at proximal thigh with <1 second refluxaaaaaaa Data to be confirmed or were not reported at the time of abstract submission. Open table in a new tab