InspireMD has announced that it has concluded enrolment in its CARENET (Carotid embolic protection study using MicroNet) clinical trial. The multi-specialty trial is assessing the peri-procedural safety and efficacy of CGuard systems in the treatment of carotid lesions. The acute procedural performance of the CGuard device was 100% successful for all of the 30 patients enrolled in the trial.
Thirty patients were enrolled at four sites across Europe and will be followed up using traditional assessments post-procedure and at 30 days to include MACE (death, stroke, MI), and ipsilateral stroke (31 days to one year). In addition, DW-MRI (Diffusion Weighted Magnetic Resonance Imaging) is being done pre and post procedure and at 30 days, as well as ultrasound examination at 30 days and one year on every patient.
The proprietary CGuard carotid embolic protection system uses the same MicroNet technology featured on the MGuard and MGuard Prime coronary embolic protection systems. The MicroNet technology is a single fibre knitted mesh wrapped on an open cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods. This technology seeks to protect patients from plaque debris and blood clots breaking off and which can lead to life threatening strokes. The size, or aperture, of the MicroNet ’pore’ is only 150-180 microns in order to maximise protection against the potentially dangerous plaque and thrombus within the carotid artery.
“I am excited that enrolment in the CGuard CARENET study has just been completed. I have treated many patients with carotid artery disease over the years and the unique CGuard embolic protection system with MicroNet has changed the way I think about treating these challenging patients,” states Joachim Schofer, from the Hamburg University Cardiovascular Center, in Hamburg, Germany. “The experience that we have gained using the CGuard device has given us a sense of confidence in regards to new technology options when treating these patients. The small pore size of the MicroNet technology allows excellent blood flow while trapping potentially harmful plaque debris and thrombus. The CGuard technology provides an elegantly simple solution for embolic protection that has not been available in the past. I look forward to reviewing and analysing all of the CARENET data over the next several weeks and sharing the results soon afterward.”
“The completion of the CGuard CARENET trial on schedule with 100% procedural success rate is an important milestone for InspireMD,” states Alan Milinazzo, president and chief executive officer of InspireMD, “Our investigators have done a wonderful job throughout this trial, and their feedback on the CGuard has been very positive and informative. The initial results support our belief that the MicroNet technology may deliver life-saving benefits to patients with carotid artery disease and revolutionise the way the carotid stenting procedures are performed. We are looking forward to analysing the data from the CARENET trial and sharing the results in mid-September at the upcoming TCT conference.”