CLINICAL DATA

ELUTAX-SV

CORONARY

The treatment of coronary de novo lesions with the ELUTAX Paclitaxel-eluting balloon alone, a pilot study - EXPEL (S.E. Jensen, Aalborg, Denmark, NCT01899235, first results presented at Joint Interventional Meeting (JIM) 2013).

Drug-eluting balloon in restenosis of drug-eluting stents: medium term follow-up (M. D’Amico, M. Pennone, Turin, Italy, published as short report in Summer edition of Hospital Cardiovascular Disease Europe (HCDE) 2014, data presented at Joint Interventional Meeting (JIM) 2014).

Effect of Drug-Coated Balloons in Native Coronary Artery Disease Left With a Dissection (B. Cortese et al., JACC: Cardiovascular Interventions 8(15), 2015, 2003-2009).

Treatment of coronary artery disease with a new-generation drug-coated balloon: final results of the Italian Elutax SV rEgistry-DCB-RISE (B. Cortese et al., J Cardiovasc Med 19(5), 2018, 247-252).

Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease, PICCOLETO II Randomized Clinical Trial (B. Cortese et al., JACC Cardiovascular Interventions 13(24), 2020, 2840-2849).

Comparison Between Sirolimus- and Paclitaxel-Coated Balloon for Revascularization of Coronary Arteries: The SIRPAC (SIRolimus-PAClitaxel) Study ( B. Cortese et al., Cardiovasc Revasc Med 28, 2021, 1-6).


PERIPHERAL

Clinical Evidence of ELUTAX-SV in Critical Limb Ischemia (R. Zahorsky, Hamburg, Germany, data presented at the CIRSE 2013).

DCB in treatment of CLI - single center experience (M. Vozar et. al., SUSCCH Banska Bystrica, Slovakia, data presented at the Vascular Surgery Congress 2014, Jasna Slovakia).

The Mid-Term Clinical Follow-Up Using Drug Eluting Balloons on Tibial Artery “De Novo” Lesions in Patients With Critical Limb Ischemia. A Cohort Study (V. Tolva et al., Vascular and Endovascular Surgery 50(5), 2016, 304-308).

Mechanical rotational thrombectomy with Rotarex system augmented with drug-eluting balloon angioplasty versus stenting for the treatment of acute thrombotic and critical limb ischaemia in the femoropopliteal segment (P. Latacz et al., Videosurgery Miniinv 14(2), 2019, 311-319).

Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Patients with Critical Limb Ischaemia: 1-Year Results of the APOLLO Trial (U. Teichgräber et al., Cardiovasc Intervent Radiol 42(10), 2019, 1380-1390).

Robotic Peripheral Vascular Intervention With Drug-Coated Balloons is Feasible and Reduces Operator Radiation Exposure: Results of the Robotic-Assisted Peripheral Intervention for Peripheral Artery Disease (RAPID) Study II (E. Mahmud et al., J Invasive Cardiol 32(10), 2020, 380-384).


FISTULA

ELUTAX-SV DEB use in hemodialysis fistulas and grafts (S. Heller et al., Prague, Czech Republic, presented at the CIRSE 2013 and at the LINC Congress 2014).

Treating recurrent stenoses in native AV fistulae using the ELUTAX DEB (R. Dey, Northampton General Hospital, Great Britain, presented at the CIRSE 2014).

Efficacy of the treatment of recurrent stenosis of vascular access with a drug eluting balloon (V. da Blanco et al., Parma, Italy, presented at Congresso Nationale Societa Italiana Nephrologia 2015).

Paclitaxel-Coated Balloon Angioplasty for Symptomatic Central Vein Restenosis in Patients With Hemodialysis Fistulas (A. Massmann et al., J Endovasc Ther. 22(1), 2015, 74–79).

Drug-Eluting Balloon Angioplasty for Juxta-Anastomotic Stenoses in Distal Radiocephalic Hemodialysis Fistulas: Long-Term Patency Results (A. Gulcu et al., Cardiovasc Intervent Radiol 42(6), 2019, 835-840).