Results of the Angioslide eXtra angioplasty balloon catheter were presented at the EuroPCR Congress (19-22 May, Barcelona, Spain) in the Peripheral Late Breaking Trials session.
Thomas Zeller, Herz-Zentrum Bad Krozingen, Germany, said that the device is a standard angioplasty balloon catheter that can double up as an embolic protection device. It shows easy ergonomics, retrieves clinically relevant particle sizes and quantities, and can be used for all applications: pre/post dilatation, in stent restenosis, post atherectomy, balloon mounted stents, and chronic total occlusion.
Zeller presented data from the MC-LEADER (Multicentre study for lower extremity angioplasty with debris removal) trial which has the purpose of demonstrating the safety and efficacy of eXtra balloon catheter. Primary efficacy endpoint is the assessment of embolic protection performance, with quantitative and qualitative analysis. Secondary efficacy endpoints are safety by major adverse events, and clinical success, acute and at 30-day follow-up.
The study was carried out in three centres, where 79 patients were treated with 148 balloons. Zeller treated 40 patients with 77 balloons in Bad-Krozingen, Dierk Scheinert, Leipzig, treated 32 patients with 57 devices, and Gunnar Tepe, Tuebingen, had seven patients treated with 14 devices.
The results for the primary endpoint showed technical success in 97% of the cases. “Particles were collected by 100% of the eXtra balloons used in the study,” said Zeller. In the secondary endpoint, acute procedural success (<50% residual stenosis) was achieved in all cases. At 30-day follow-up, 88% of the patients described a moderate or marked improvement in symptons as measured by Rutherford-Becker improvement score.
The total number of particles removed from the 79 patients was 45,665, with 63 to 4,947 particles per balloon. The median number of particles per subject was 343. Of the patients, 25.3% had between 101 and 200 particles, and 10.1% had more than 1,000 particles. Regarding maximum major axis, 25% of the subjects had a particle >2mm, 11% had a particle >4mm, 7% had a particle >5mm, and 6% had a particle >6mm. The histology showed chronic thrombus, foam cells, calcium crystals and necrotic core with cholesterol clefts.
“This was a first feasibility and safety study in the femoropopliteal area using a unique angioplasty device. The device will not generate significant higher costs as compared to a regular balloon catheter as long as only one device has to be used,” Zeller told Interventional News. “Considering this, the eXtra angioplasty balloon should at least become standard of practice in patients with compromised distal outflow where distal embolism could potentially lead to a disastrous outcome such as amputation. Potential other areas of use are renal arteries, carotids and even coronary arteries, here in particular degenerated bypass grafts. Further studies in these vessel areas are mandatory.”
The eXtra device is commercially available in Europe. FDA clearance is expected in June. Additional clinical trials are planned.