Cagent Vascular announced the results of its PRELUDE-BTK study at LINC 2021 (25–29 January, online). The PRELUDE-BTK study was a prospective, single-arm, multicentre feasibility study to show the safety and efficacy of serration angioplasty.
The study was led by co-principal investigators, Andrew Holden (Auckland City Hospital, Auckland, New Zealand), who presented the data, and Michael Lichtenberg (Karolinen Hospital, Arnsberg, Germany). Four other centres from Europe participated in the trial which included 30-day and six-month follow-up.
According to a Cagent Vascular press release, the Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter is the first and only angioplasty balloon cleared by the US Food and Drug Administration (FDA) and CE marked that embeds serration technology into a semi-compliant balloon for treating peripheral arterial sisease (PAD). The device is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion.
Forty-six subjects were treated with the Serranator device and 53 lesions were analysed by the core lab. The average final residual stenosis was 21.8%, with an average below-the-knee (BTK) arterial lumen gain of 1.55mm. These results were achieved with a low average maximum atmospheric pressure of six atmospheres. The bailout stent rate was 1.9%. A subset of lesions (n=10) were imaged with optical coherence tomography (OCT) and intravascular ultrasound (IVUS) and analysed 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 revascularisation (CD-TLR) was 97.7% with 70% of subjects achieving one or more Rutherford clinical category (RCC) improvement at six months. There were no serious adverse events related to the device.
“Today, we have insufficient data for effective lesion revascularisation in BTK arteries. Based on published plain balloon angioplasty 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 stabilise the lumen and prevent diminished outflow. This revascularisation strategy is associated with poor patency outcomes,” stated Lichtenberg.
“The PRELUDE study clearly proved the hypothesis, that haemodynamic and morphologic success in BTK revascularisation 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, non-compliant 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 six months,” continued Lichtenberg.
The Serranator product offering for the infrapopliteal indication is available in 2.5, 3, and 3.5mm balloon diameters and 40, 80, and 120mm balloon lengths. The company has initiated US and EU sales and plans to expand its commercial efforts later this year.