title: Improved outcome with novel device for low-pressure PTCA in de novo and in-stent lesions.
abstract: OBJECTIVE
  Complex lesion morphology requiring the use of high pressure to effect lumen expansion and in-stent restenosis (ISR) remain two indications that challenge conventional PTCA balloons. We report on a new PTCA device that is designed to provide precise, low-pressure dilatation of both de novo and in-stent lesions.
  
  
  METHODS
  The FX miniRAIL catheter (FX) has an integral wire positioned external to a dilating balloon and a short, 12-mm guidewire lumen distal to the balloon. The balloon inflates against the guidewire and the external wire to prevent slippage and to introduce high focal longitudinal stresses at low inflation pressures. In this initial study, the FX was used in 37 lesions (25 de novo, 12 in-stent; vessel reference diameter=2.73+/-0.49 mm) in 30 patients. A stepwise inflation protocol and QCA were used to determine the balloon pressure at which the stenosis was resolved (stenosis resolution pressure, SRP).
  
  
  RESULTS
  All lesions (100%) were easily reached, crossed and dilated without complication. The SRP was 4.5+/-2.9 atm, and no balloon slippage was observed. Residual stenosis after FX was 26.39+/-13.29%. Minor dissections (Types A and B) were observed in eight lesions (21.6%). Target lesion revascularization (TLR) and target vessel revascularization (TVR) at follow-up (8.1+/-1.5 months) were 8.3% and 12.5%, respectively.
  
  
  CONCLUSIONS
  The design of the FX is versatile and appears to provide for a safe, effective and improved low-pressure PTCA technique in de novo and in-stent lesions.
authors.affiliation: Division of Cardiology, Klinikum Bogenhausen, Munich, Germany.
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Ischinger
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Solar
authors.forename: Evelyn
authors.initials: E
authors.lastname: Hitzke
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy; D004864:Equipment and Supplies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome