Avinger, Inc., a developer of the next generation of catheter-based technologies for the treatment of cardiovascular and peripheral vascular diseases, announced the enrollment of the first patient in the CONNECT (chronic total occlusion crossing with the wildcat catheter) clinical trial. The CONNECT trial is a prospective, multi-center, non-randomised study intended to evaluate the wildcat catheter's ability to cross chronic total occlusions in femoropopliteal lesions.
Patients with peripheral artery disease may have chronic total occlusions which are sometimes difficult to treat with endovascular therapy resulting in either bypass surgery or amputation. The ability to cross chronic total occlusions (CTOs) enables subsequent endovascular treatment of peripheral artery disease and is directly related to acute procedural success and favorable long-term outcomes.
The wildcat catheter crosses CTO lesions by creating a small channel through the blockage using retractable spiral wedges creating a corkscrew effect enabling further treatment of the lesion with therapeutic devices. The wildcat catheter received US FDA 510(k) clearance in February 2009 for use as a guidewire support device to access discreet areas of the vasculature. Avinger is conducting this study to secure US FDA clearance for an indication specific to crossing CTOs.
"We are very excited by this new technology," said Dr Thomas Davis, St John Hospital and Medical Center, who enrolled the first patient in the CONNECT trial. "If we were not able to cross this CTO with the wildcat, the only other option for this patient would have been a surgical bypass or amputation. With the help of this technology we will hopefully be able to change the paradigm of treatment from surgical to endovascular."
The CONNECT study will evaluate 88 PAD patients with femoropopliteal CTO lesions at 15 centers in the US. Patients will be followed for 30 days post procedure and an independent group of physicians will review the angiography results to determine crossing efficacy and safety. Conditional FDA approval to conduct this study was received on August 11, 2010. Co-Principal investigators for the trial are Dr Thomas Davis of St John Hospital and Medical Center in Detroit, Michigan and Dr Laiq Raja of El Paso Cardiology Associates, P A and Providence Memorial Hospital in El Paso, Texas.