PRELUDE-BTK Study Results Presented for Cagent Vascular’s Serranator Device

February 1, 2021—Cagent Vascular announced results of its PRELUDE-BTK study, a prospective, single-arm, multicenter feasibility study to show the safety and efficacy of percutaneous transluminal angioplasty (PTA) in below-the-knee (BTK) lesions with the company’s Serranator technology.

The FDA-cleared and CE Mark–approved Serranator PTA balloon catheter embeds serration technology into a semicompliant balloon to treat peripheral artery disease. The device is designed to create multiple longitudinal lines of interrupted microserrations to aid arterial expansion.

The study was led by Coprincipal Investigators Andrew Holden, MBChB, from Auckland City Hospital in Auckland, New Zealand, and Michael Lichtenberg, MD, from Klinikum Hochsauerland in Arnsberg, Germany. Four other centers in Europe participated in the trial, which included 30-day and 6-month follow up.

Dr. Holden presented the results at LINC 2021, the Leipzig Interventional Course held as a virtual event January 25-29.

According to Cagent Vascular, the study included 46 patients treated with the Serranator device and 53 lesions that were analyzed by the core lab. The average final residual stenosis was 21.8%, with an average BTK arterial lumen gain of 1.55 mm. These results were achieved with a low average maximum atmospheric pressure of 6 atmospheres. The bailout stent rate was 1.9%.

A subset of lesions (n = 10) were imaged with optical coherence tomography and intravascular ultrasound and analyzed by a core lab. All showed a serration effect. At 30 days, the freedom from primary safety events was 95.7%. The freedom from clinically driven target lesion revascularization (CD-TLR) was 97.7%, with 70% of subjects achieving one or more Rutherford classification improvement at 6 months. There were no serious adverse events related to the device.

In Cagent Vascular’s press release, Dr. Lichtenberg commented, “Today, we have insufficient data for effective lesion revascularization in BTK arteries. Based on published plain old balloon angioplasty (POBA) data, especially in calcified lesions, more than 40% of the cases result in complex dissections and significant recoil phenomenon. This ultimately leads to scaffold implantation to stabilize the lumen and prevent diminished outflow. This revascularization strategy is associated with poor patency outcomes.”

Dr. Lichtenberg continued, “The PRELUDE study clearly proved the hypothesis that hemodynamic and morphologic success in BTK revascularization is strongly associated with vessel compliance improvement. We need to concentrate first on this aspect before we can discuss the need for longer-term restenosis prevention with antiproliferative substances. We know that dissections are directly associated with loss of patency and impaired wound healing. Prevention of dissections within a rigid, noncompliant vessel, along with luminal gain can only be successful with a vessel wall modification device that applies low atmospheres. The PRELUDE-BTK study clearly showed that the mechanism of action works well enough that it does not even need additional antiproliferative treatment, as CD-TLR was only 2.3% after 6 months.”

Venita Chandra, MD, a vascular surgeon from Stanford University in Stanford, California, added, “I have been very impressed with the luminal gain that can be achieved at low atmospheric pressures provided by serration angioplasty, even in heavily calcified vessels. In addition, the luminal gain in the setting of minimal dissection and less vessel recoil than POBA make this a very compelling new tool for BTK disease. I also think this is a very promising tool for pedal arch angioplasty.”

The Serranator product offering for the infrapopliteal indication is available in 2.5-, 3-, and 3.5-mm balloon diameters and 40-, 80-, and 120-mm balloon lengths. The company has initiated United States and European sales and plans to expand commercial efforts later this year, advised Cagent Vascular.