Purpose: 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.
Conclusion: 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.
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