Cagent Vascular Announces Results From the PRELUDE Study
February 7, 2018—Cagent Vascular announced that 30-day results and preliminary 6-month data from the company's PRELUDE study were presented by Principal Investigator Andrew Holden, MBChB, at LINC 2018, the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany.
PRELUDE is evaluating the safety and efficacy of Cagent Vascular's Serranator Alto percutaneous transluminal angioplasty serration balloon catheter in critical lesions in the superficial femoral artery (SFA) and/or popliteal arteries. The prospective, single-arm, multicenter feasibility study enrolled 25 patients at centers in New Zealand and Europe.
According to the company, the primary objective was the technical feasibility of using the Serranator in critical SFA or popliteal artery lesions. The secondary objective was the feasibility of using optical coherence tomography (OCT) and/or intravascular ultrasound (IVUS) in a subset of patients (n = 10) to evaluate the presence of serrations.
In the study, 80% of treated lesions (n = 20) were in the SFA, 56% of treated lesions had moderate to severe calcification, and 32% of treated lesions were chronic total occlusions.
The pretreatment diameter stenosis was 87.6%. The final diameter stenosis was 22.7% using just the Serranator device. The mean luminal gain was 3.45 mm in the severe group (n = 7), which required 8.57 atm of maximum pressure, versus 3.33 mm in the none-to-moderate group (n = 18) using 7.67 atm.
There were no flow-limiting dissections and one bailout stent was used. All patients who underwent OCT or IVUS showed a serration effect as analyzed by the core lab. Patency was 100% at 30 days as assessed by duplex ultrasound, and freedom from target lesion revascularization was 100% at 30 days and 6 months.
In the company's announcement, Dr. Holden commented, "The fascinating part of the trial is that although we had patients, by definition, who were excluded with severe calcification, there was a significant core lab–adjudicated group of patients who had lesions with moderate to severe calcification. We could achieve luminal gain to nominal using very low pressures in that subgroup, which tells us that this is something quite different from plain balloon angioplasty."
Dr. Holden continued, "Not only being able to dilate these vessels to nominal, which is an achievement on its own, but to do it without a significant incidence of dissection is an achievement. Although the numbers are small this is a really encouraging sign that the serration mechanism of action is a very different way of treating the artery."
In February 2017, Cagent Vascular announced US Food and Drug Administration 510(k) clearance of the Serranator Alto, which is the company's first product. It is indicated for dilatation of lesions in the iliac, femoral, iliofemoral, and popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
In November 2017, the company announced European CE Mark approval for the device.
The PRELUDE-BTK study is expected to begin in 2018 to evaluate the device in the treatment of lesions below the knee, advised the company.