title: Final results of the Chronic Total Occlusion Crossing With the Ocelot System II (CONNECT II) study.
abstract: OBJECTIVE
  To evaluate the safety and effectiveness of the optical coherence tomography-guided Ocelot catheter to cross femoropopliteal chronic total occlusions (CTOs).
  
  
  METHODS
  The CONNECT II study was a prospective, multicenter, non-randomized single-arm study of the safety and effectiveness of the Ocelot catheter in CTO crossing. Key inclusion criteria were a 99% to 100% stenosed femoropopliteal segment, lesion length between 1 and 30 cm, and resistance to guidewire crossing. The main exclusion criterion was a severely calcified target vessel. The primary safety endpoint was 30-day major adverse events (MAE), while the primary effectiveness endpoint was successful CTO crossing (i.e., guidewire placement in the distal true lumen) with the Ocelot catheter. Endpoint analysis was based on pre-specified objective performance criteria. Between February and June 2012, 100 patients (55 men; mean age 69 years) were enrolled. Most of the CTOs (94%) were in the superficial femoral artery (SFA); mean lesion length was 16.6±9.3 cm.
  
  
  RESULTS
  Through 30 days, 2 patients experienced MAE (significant perforations) related to the Ocelot catheter. The Ocelot catheter successfully crossed 97% of target CTOs either alone (72%), in conjunction with an assist device (18%), or in conjunction with a re-entry device (7%). Both primary safety and effectiveness endpoints were met.
  
  
  CONCLUSIONS
  The Ocelot catheter with optical coherence tomography guidance offers physicians a reliable option for crossing femoral and popliteal chronic total occlusions with low MAE rates.
authors: 1 Heart Hospital of Austin, Texas, USA.
authors: Matthew R
authors: MR
authors: Selmon
authors: Arne G
authors: AG
authors: Schwindt
authors: Ian M
authors: IM
authors: Cawich
authors: Jack R
authors: JR
authors: Chamberlin
authors: Tony S
authors: TS
authors: Das
authors: Tom P
authors: TP
authors: Davis
authors: Jon C
authors: JC
authors: George
authors: Sean F
authors: SF
authors: Janzer
authors: Lou A
authors: LA
authors: Lopez
authors: Huey B
authors: HB
authors: McDaniel
authors: James F
authors: JF
authors: McKinsey
authors: John P
authors: JP
authors: Pigott
authors: M Laiq
authors: ML
authors: Raja
authors: Bernard
authors: B
authors: Reimers
authors: Ted L
authors: TL
authors: Schreiber
mesh_terms: D000368:Aged; D002908:Chronic Disease; D002983:Clinical Competence; D003251:Constriction, Pathologic; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006801:Humans; D059032:Learning Curve; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging; D011446:Prospective Studies; D011859:Radiography; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014481:United States; D062666:Vascular Access Devices