title: New approach to protected percutaneous transluminal angioplasty in the lower limbs.
abstract: OBJECTIVE
  To provide evidence for the safety and efficacy of the Proteus embolic capture balloon in lower limb interventions and to evaluate its indications for use.
  
  
  METHODS
  The study was designed as a prospective, multicenter, non-randomized, single arm study enrolling 123 patients (78 men; mean age 68 years). The primary endpoint was rate of freedom from death, amputation, and target vessel revascularization (TVR) at 30 days post procedure. Follow-up was performed at 30 days and at 12 months.
  
  
  RESULTS
  The freedom from death, amputation, and TVR rate was 95.9% (118/123). Procedure and device success rates were 98.7% (218/223) and 97.8% (156/158), respectively. TVR and death rates at 12 months were 18.8% and 4.1%, respectively. Histological analysis identified particles in 100% of the balloons. The median number of particles per subject was 339 (range 63-4361). Medians of particle size and total particle area were 0.8 (range 0.3-8.3) and 1.0 mm(2) (range 0.1-237) per balloon, respectively. Particles >1 mm were found in 37% (53/143) of the balloons analyzed. Higher mean number, length, and surface area of particles were found in long lesions (909±1057, 2.6±2.3 mm, and 18.2±44.2 mm(2), respectively; all p<0.0001 vs. short lesions). Additionally, longer particles were found in total occlusions (2.5±2.5 mm, p<0.0001), and a higher mean particle count was found in thrombotic lesions (1785±1821, p<0.05). De novo lesions had more thrombotic material than any other type of lesion.
  
  
  CONCLUSIONS
  Proteus demonstrated good particle capture ability, making it a useful tool in situations where embolism is anticipated, such as complex lesions with calcified or thrombotic material and/or lesions with high plaque burden (i.e., long and totally occluded).
authors.affiliation: Department of Angiology, Universitaets-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany. thomas.zeller@universitaets-herzzentrum.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Andrej
authors.initials: A
authors.lastname: Schmidt
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.forename: Elias
authors.initials: E
authors.lastname: Noory
authors.forename: Klaus
authors.initials: K
authors.lastname: Brechtel
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sixt
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Gunnar
authors.initials: G
authors.lastname: Tepe
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000295:instrumentation / Q000379:methods*; D004617:Embolism / Q000601:surgery*; D005260:Female; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome