Cagent Vascular has announced the results of its below-the-knee (BTK) RECOIL study. This core lab-adjudicated Recoil analysis— the first of its kind, according to the company— evaluated vessel recoil in lesions treated with Serranator verses plain balloon angioplasty.
The study results demonstrated that lesions treated using serration angioplasty exhibited 49% less average recoil than plain balloon angioplasty. Stefan Stahlhoff (Arnsberg Clinic, Arnsberg, Germany) and Venita Chandra (Stanford University, Stanford, USA) led the RECOIL study as co-principal investigators.
The Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter is the first and only angioplasty balloon that is US Food and Drug Administration (FDA) cleared and CE marked that embeds serration technology into a semi-compliant balloon for treating peripheral arterial disease (PAD), a press release reads. The device is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion.
Thirty-six patients with 39 lesions in up to 22cm in length were matched 1:1 using either the Serranator or plain balloon angioplasty. The study objectives were to assess the ability to define and measure post treatment recoil in infrapopliteal arteries and to show preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post-treatment recoil, lumen gain, and dissection. In each procedure the lumen diameter was measured immediately post angioplasty and then again at 15 minutes post inflation. The degree of vessel recoil was assessed angiographically and then core lab adjudicated. These data showed a mean percent recoil of 6% in the Serranator group vs. 55% in the plain balloon angioplasty group representing a 49% reduction in recoil using serration angioplasty. Notably, there were no flow limiting dissections in either lesion treatment group, suggesting that optimal inflation technique impacts dissection rates, but not recoil rates.
“The recoil phenomenon is well understood as one of the greatest headwinds to successful BTK treatment and ultimately wound healing,” stated Michael Lichtenberg (Klinikum Hochsauerland, Arnsberg, Germany) who participated in the study. “The 49% difference demonstrated in the RECOIL study between Serranator and [plain balloon angioplasty] is statistically significant and in my view also clinically relevant. Wound healing requires a durable lumen to support brisk blood flow, and 55% recoil for [plain balloon angioplasty] treated lesions is a signal that our current 40-year [plain balloon angioplasty] standard therapy is inadequate. I believe this study is a further step in demonstrating serration angioplasty as a definitive treatment for BTK lesions.”
Chandra added: “We know that BTK interventions are highly susceptible to vessel recoil, however the impact of recoil on residual stenosis at 15 minutes post procedure makes the true severity of this challenge clear. Our [chronic limb-threatening ischaemia] patient population is particularly vulnerable and at greater risk of limb loss and the associated increase in mortality that accompanies amputation. While this initial RECOIL study did not follow patient outcomes, in the future we intend to evaluate how impactful serration angioplasty’s recoil improvement is to healing BTK wounds and savings limbs. The results from this comparative RECOIL study are indicative that serration angioplasty may be the tool that finally addresses this longstanding challenge with [plain balloon angioplasty].”