title: Application, feasibility, and efficacy of a combined intravascular ultrasound and stent delivery system: results from a prospective multicenter trial.
abstract: BACKGROUND
  Intravascular ultrasound (IVUS) is the reference method for in vivo assessment of vessel dimensions and coronary plaque composition, which can influence device selection as well as stent sizing.
  
  
  OBJECTIVE
  The objective of this prospective multicenter-study was to test the application, safety, and feasibility of a new combined IVUS and stent delivery system.
  
  
  METHODS
  A total of 32 patients with planned direct stent implantation under IVUS guidance were included in the study. Procedural as well as angiographical and IVUS characteristics of the stent implantation with the combined IVUS and stent delivery system were assessed and compared to a historical control cohort where IVUS-guided stenting was performed with a separate IVUS catheter.
  
  
  RESULTS
  Direct stent placement was successfully performed in all patients and no malfunctions of the system were noted. A post-interventional IVUS assessment was possible in 27 (87%) of the 31 patients. The IVUS information led to a change in therapeutic strategy in 16 (50%) of the 32 patients. In the study group, both the procedural time and the amount of contrast dye were significantly lower than in the historical IVUS-guided stenting control group. A clinical 12-month follow-up revealed a 89% event-free survival and a target vessel revascularization rate of 7%.
  
  
  CONCLUSIONS
  The use of a combined IVUS and stent delivery device is safe, easy to handle, and can provide helpful additional information to guide a percutaneous coronary interventions procedure. Beyond angiography, these informations had significant impact on the interventional strategy in these patients, which resulted in a low rate of major adverse cardiac events. The concept of combining IVUS information and a stent delivery system may be increasingly attractive with evolving imaging modalities like virtual histology or a combination with drug-eluting stents.
authors.affiliation: Department of Cardiology, Division of Internal Medicine, University of Munich, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Rieber
authors.forename: Katharina
authors.initials: K
authors.lastname: Gockel
authors.forename: Dietmar
authors.initials: D
authors.lastname: Koschyk
authors.forename: Isabelle
authors.initials: I
authors.lastname: Erhard
authors.forename: Andreas
authors.initials: A
authors.lastname: Koenig
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Schiele
authors.forename: Karl
authors.initials: K
authors.lastname: Theisen
authors.forename: Uwe
authors.initials: U
authors.lastname: Siebert
authors.forename: Volker
authors.initials: V
authors.lastname: Klauss
mesh_terms: D000368:Aged; D019917:Blood Vessel Prosthesis Implantation; D017023:Coronary Angiography; D003327:Coronary Disease / Q000175:diagnosis / Q000601:surgery; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012107:Research Design; D015607:Stents; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional