Avinger announced on 9 September 2010 the enrolment of the first patient in the CONNECT (Chronic total occlusion crossing with the WildCat Catheter) clinical trial. The CONNECT trial is a prospective, multicentre, 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 favourable 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 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 FDA clearance for an indication specific to crossing CTOs.
“We are very excited by this new technology,” said Thomas Davis of 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 peripheral arterial disease patients with femoropopliteal CTO lesions at 15 centres in the USA. 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 11 August 2010. Co-principal investigators for the trial are Thomas Davis of St John Hospital and Medical Center in Detroit, and Laiq Raja of El Paso Cardiology Associates, PA and Providence Memorial Hospital in El Paso.
“Avinger was created to develop technologies that change the way vascular disease is treated today,” said Avinger CEO John B Simpson. “The CONNECT trial will provide clinical data to help guide physicians in the use of the Wildcat and provide expanded treatment options for peripheral arterial disease. We hope that Avinger can play a key role in helping patients facing an amputation keep their leg.”