title: Characterization of alteplase (tPA) following delivery through the AngioJet rheolytic catheter.
abstract: OBJECTIVE
  To analyze alteplase solutions following delivery through the AngioJet Xpeedior rheolytic thrombectomy device to characterize the viability of proteins exposed to high shear stress.
  
  
  METHODS
  Alteplase solutions were prepared by reconstitution in sterile water to obtain a targeted concentration of 1.0 mg/mL. A baseline control sample was obtained. The AngioJet system was modified by occluding the return line to allow collection of the dispersed fluid volume. Alteplase solutions (n=5) were delivered through the 6-F, 120-cm Xpeedior catheter and collected. All samples were assayed and compared to baseline using qualitative visual inspection, ultraviolet spectrophotometry, size exclusion chromatography, and in vitro clot lysis assays.
  
  
  RESULTS
  Analysis of the test solutions demonstrated a mean protein recovery of 98.0%+/-3.5% of targeted concentration; the collected protein was fully active, as determined by clot lysis assays (specific activity > or =100%). All samples were clear and colorless. No significant fragmentation or aggregation of protein was observed.
  
  
  CONCLUSIONS
  Alteplase solutions, when delivered through the AngioJet Xpeedior rheolytic thrombectomy device, remain stable and biologically active in vitro. Further clinical investigation is warranted using this method as a novel approach for pharmacomechanical thrombolysis.
authors.affiliation: Division of Vascular Medicine and Neurology, Genentech, Inc., South San Francisco, CA 94080-4990, USA. cpsemba@gene.com
authors.forename: Charles P
authors.initials: CP
authors.lastname: Semba
authors.forename: Suzanne
authors.initials: S
authors.lastname: Weck
authors.forename: Mahmood K
authors.initials: MK
authors.lastname: Razavi
authors.forename: Cindy M
authors.initials: CM
authors.lastname: Setum
authors.forename: Thomas
authors.initials: T
authors.lastname: Patapoff
mesh_terms: D002404:Catheterization / Q000379:methods*; D016503:Drug Delivery Systems; D004867:Equipment Design; D004869:Equipment Safety; D006801:Humans; D066298:In Vitro Techniques; D011673:Pulsatile Flow; D012680:Sensitivity and Specificity; D017131:Thrombectomy / Q000295:instrumentation* / Q000379:methods; D013927:Thrombosis / Q000628:therapy; D010959:Tissue Plasminogen Activator / Q000494:pharmacology*
chemical_list: D010959:Tissue Plasminogen Activator