First Patients Enrolled in CONNECT II Global Trial

  • Cardiology Today's Intervention, May/June 2012

CONNECT II, a global trial that will test the first-ever chronic total occlusion crossing catheter to use optical coherence tomography, has enrolled its first US patient, according to a press release.

The announcement came just 2 weeks after the first European patient was enrolled in the trial in Mirano, Italy.

The prospective, nonrandomized CONNECT II trial will test the catheter (Ocelot, Avinger) in 100 patients with peripheral arterial disease and femoropopliteal CTO lesions at 17 sites, including three in the European Union, where the device received CE Mark approval in 2011. Trial co-principal investigators include Arne Schwindt, MD, of St. Franziskus Hospital in Muenster, Germany, and Matthew Selmon, MD, from the Austin Heart Hospital in Austin, Texas.

Perspective
Lawrence A. Garcia, MD

Lawrence A. Garcia

  • Ocelot is the first occlusion catheter that allows an operator the ability to image using an OCT fiber to determine where they are in an artery as they cross a total occlusion. It uses a crosshair system in the representative real-time image that includes one vertical and two horizontal hatchet marks. The vertical hatchet mark is the side that has the OCT fiber. If the operator places this mark on the three-layered luminal structure he knows he is against the true luminal surface and can direct the catheter away from this side, which in essence keeps them directed toward the true luminal space. Many have advocated that staying in a luminal surface allows you a better outcome (ie,patency in the superficial femoral artery). Currently, despite a lack of data to support this theory, it does open up the opportunity for a greater multitude of therapies to include debulking (atherectomy) or other therapies, which may have a potential impact on the long-term patency in treating this very difficult anatomic lesion.
    • Lawrence A. Garcia, MD
    • Chief, Interventional Cardiology and Vascular Interventions
      St. Elizabeth’s Medical Center, Brighton, Mass.
  • Disclosures:Dr. Garcia reports no relevant financial disclosures.

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