PRELUDE-BTK Study Update: Serranator Balloon Catheter Feasibility Study

During a late-breaking clinical trial session at AMP 2020 Virtual, Michael Lichtenberg, MD, from the Arnsberg Vascular Clinic in Arnsberg, Germany, presented an update of the PRELUDE-BTK study, a feasibility study of the new Serranator PTA Balloon Catheter (Cagent Vascular).

“We know about the insufficiency of standard balloon angioplasty, especially in BTK disease, and especially in patients with critical limb ischemia,” said Lichtenberg. Limits include insufficient lumen gain, recoil, barotrauma, flow-limiting dissections, the forced use of bailout stenting, which leads to multiple re-interventions and poor long-term patency.

There's a clear need to have a technology for below-the-knee interventions and the Serranator PTA Balloon Catheter may be just such a technology. This FDA cleared and CE marked semicompliant balloon device comes with metal 3 serrated strips and it runs over an over-the wire, 0.14” and requires a 6-French sheath.

The device is intended for dilatation of lesions in infrapopliteal arteries and is not for use in coronary or neurovasculature indications.

Preliminary data, said Dr. Lichtenberg, indicated that “the serration technology may be the needed revolution in plain old balloon angioplasty (POBA). The Serranator appears to offer the simplicity of POBA and addresses the versatility needed below the knee.”

“The idea behind the serration technology is that the serrations create linear and circumferential expansion. It enables predictable and controlled lumen expansion along the lines…so this is a new concept of scoring, especially for below-the-knee vessels.

The PRELUDE-BTK study aims to assess the safety and efficacy of this device. It is a multicenter feasibility study being conducted in Europe and New Zealand. Forty-nine patients with critical infrapopliteal artery lesions have already been enrolled.

Thirty-day and 6-month follow-up in in progress and will include OCT and IVUS imaging in some patients, to provide more information about the effects of the serrated technology.

The primary endpoint for safety is a composite of major adverse limb events (MALE) and peri-procedural death (POD) assessed at 30 days post procedure. MALE plus POD is defined as a composite of all-cause death, thrombolysis/thrombectomy at the target lesion, open surgical revision or bypass, and major (above ankle) target limb amputation at 30 days.

Procedural efficacy will be assessed by the rate of device success, defined as the achievement of successful insertion, balloon inflation and deflation, and removal of the study device with a final diameter stenosis of <50% by visual assessment at the intended target site using only the Serranator device.

The inclusion and exclusion criteria and secondary endpoints are the standard ones used in these types of studies.

They demonstrate the effectiveness of the device. Dr. Lichtenberg presented a case of a challenging, long, chronic total occlusion in the posterior tibial artery that was treated, leaving a residual stenosis of 15%, with “brisk” post-treatment run-off and no dissections.

Proof of concept of the device has been demonstrated by Dr. Andrew Holden who demonstrated with OCT serrations in the intimal surface of a severely calcified tibioperoneal trunk with no dissections.

“Preliminary data show excellent lumen gain and low atmospheric pressure required,” said Dr. Lichtenberg.