Cagent Vascular initiates the Serranator POINT FORCE observational registry

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RECOIL study
Serranator

Cagent Vascular has announced the start of the POINT FORCE registry, a postmarket clinical follow-up study of the Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter.

This prospective, multicentre, single-arm study will enrol a minimum of 500 patients at up to 30 centres in the USA. The objective of this study is to evaluate the safety and efficacy, under local standard of care, of serration angioplasty for the treatment of peripheral arterial disease (PAD) throughout the entire leg.

The primary endpoint for this study is device success, defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device with a post-Serranator residual stenosis of ≤30%, as assessed by an independent angiographic corelab. Yale Cardiovascular Research Group in New Haven, USA, will serve as the corelab for this study.

Led by national co-principal investigators (PIs) S Jay Mathews (Manatee Memorial Hospital, Bradenton, USA) and Michael Siah (University of Texas Southwestern [UTSW] Medical Center, Dallas, USA), this registry will build the body of clinical evidence for serration angioplasty. Siah enrolled the first POINT FORCE patient.

“We’re excited to launch the POINT FORCE registry with the initial enrolment here at UTSW,” said Siah. “Serranator is a key part of our ATK [above-the-knee] and BTK [below-the-knee] treatment algorithm, and our team is eager to analyse this large, corelab-adjudicated dataset to capture the results of treating with serranation across a wide spectrum of treatment strategies and clinical presentations.”

“We know from prior corelab-adjudicated studies that Serranator provides an efficacious result for patients, with a very low rate of complication and mitigated recoil,” stated Mathews. “What we endeavor to understand in POINT FORCE is the role serranation can play in routine clinical practice. We anticipate reviewing iliac, fempop, infrapop, and inframalleolar vessel territories, along with AV [arteriovenous] access.”

Brian Walsh, chairman and chief executive officer of Cagent Vascular, added: “Despite having performed over 20,000 procedures, Serranator remains a new and disruptive PAD therapy. We expect POINT FORCE will illuminate the benefits of serranation and help share the impact in all common clinical algorithms. We’re excited to get started and grateful for the support of our PIs and all participating centers.”


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