The Preliminary 30-day results from the Phase I Carotid Revascularisation with ev3 Arterial Technology Evolution (CREATE) trial have been presented in a late-breaking trials session at the Society of Interventional Radiologists (SIR) meeting in April, in New Orleans, LA. The results demonstrated that the Prot©g© GPS Self-Expanding Stent has a lower rate of myocardial infarction, stroke or death 30 days after treatment than its predecessor. The trial involved 419 patients. In this cohort, 60% were men and the average age was 74 years. The rate of major adverse cardiac events at 30 days for the Prot©g© stent and the Spider Embolic Protection Device was 4.8%, according to Dr Robert D Safian, medical director of cardiac and vascular intervention, William Beaumont Hospital, Royal Oak, MI, Principal Investigator for the CREATE Trial. The SpideRX Device, like its predecessor product, has a unique nitinol filter. The new device is designed to provide more efficient delivery, capture and recovery, while still allowing interventionalists to use their interventional wire of choice. Improvements over the current device include a complete rapid exchange system, 6Fr guide catheter compatibility and a unique dual-end delivery/recovery catheter with a pre-loaded capture wire.
The researchers also found that successful stent deployment was achieved in 97.8% of procedures. Success was defined as deployment and recapture of the filter, stent deployment over the filter, and final stenosis in fewer than 50%. The major adverse cardiac events rate typically ranges from 11% to 15% at 30 days in endarterectomy trials. Previously, the Acculink for Revascularisation of Carotids in High Risk Patients (ARCHeR) trial achieved a rate of 7.8% at that time point.
Data at 30 days were obtained on 400 patients; 17.5% were symptomatic. High-risk patients were those with greater than 75 years of age (50.3% of patients), with history of restenosis (23.3%), with coronary artery disease affecting more than two vessels (14.3%), left ventricular ejection of less than 35% (9.5%), and severe pulmonary disease (4.0%). Among the overall patient group, 39.5% fulfilled two or more of these criteria. The overall major adverse cardiac events rate at 30 days was 4.8%. The mortality rate was 1%; the rate for any stroke was 3.3%, 2.3% for major stroke; the rate for myocardial infarction was 0.5%. The Prot©g© stent is available in four lengths: 20, 30, 40, and 60mm. Dr. Safian noted that the 60-mm stent is especially useful in tubular lesions that involve crooked carotids; previously treatment of such cases required placement of two or more shorter stents.
In addition, ev3 has received approval to include the SpideRX Embolic Protection Device in the second arm of the company’s CREATE clinical trial. ev3 has completed enrolment in the first phase of this trial using the Spider Embolic Device and the Protege GPS Self-Expanding Stent. The second phase of the trial will evaluate the SpideRX Device when used with the approved and commercially available RX Acculink Carotid Stent System, from Guidant.
“We believe it will provide our investigators with the opportunity to gain important clinical experience with our rapid exchange embolic protection system and the already available RX Acculink Stent System. This will demonstrate the SpideRX Device compatibility with both the Protege and the RX Acculink,” stated Ginny Kirby, vice president of clinical affairs at ev3.
The SpideRX Device is currently commercially available in Europe and several countries in Latin America and Asia