Early results with a monorail-stent-balloon device for endovascular treatment of renal artery stenosis

Objective: To evaluate the technical feasibility of a new monorail-stent-balloon device for treatment of renal artery stenosis (RAS). Patients and Methods: During a study period of 18 months, 38 patients with proven RAS in 41 cases (hypertension n=36, renal insufficiency n = 13) and indication for stenting (calicified ostial lesions n = 35, insufficient PTA n = 4, dissection n = 2) were enrolled into this prospective evaluation. Pre-mounted stents (Rx-Herculink(TM) 5 mm = 13, 6 mm = 34, 7 mm = 1) were implanted a transfemoral (n=35) or transbrachial approach (n = 6). Mean grade and lengths of stenosis measured were 88 % 10 and 9 mm +/-5. Results: Renal stent implantation was technically successful in ail cases (100%). In 7 cases a second stent had to be implanted to cover the entire lesion. The transstenotic pressure drop decreased from 88 mmHg +/-10 before to 1 mmHg +/-1.8 after the procedure. Remaining stenosis measured 0.7% +/-4.2. Serum creatine levels decreased from 1.9 mm/dl to 1.5 mg/dl (n.s.), blood pressure decreased from 178/94 mmHg to 148/79 mmHg (p <0.0001) after the intervention. Primary and secondary patency rates at 6 months were 72 % (Standard Error 9.8 %) and 77 (% (Standard Error 9.2 %), respectively. Conclusion: With the used monorail-stend-balloon device a technically easy, secure and exact renal stent placement is guaranteed, patency rates are similar to those described in the current literature.