Clinical News

related outcomes between patients randomised to the AFX endograft system, with anatomical fixation, and commercially available endografts with proximal fixation.

Cook Medical treats first patient in first-in-human clinical trial for venous valve

Cook Medical recently announced that the first patient has been treated in a clinical study to evaluate a new venous valve designed for treating chronic venous insufficiency (CVI). The patient was treated by principal investigator Mauricio Alviar (Clinica de la Costa, Barranquilla, Colombia).

The valve’s safety and efficacy are now being tested in a global, multisite clinical trial. The global principal investigator of the study is Paul Gagne (Vascular Care Connecticut, Darien, USA). In addition to being a practicing surgeon and interventionist, a press release notes that Gagne brings significant experience in performing clinical trials of minimally invasive vascular medical devices.

“When leg veins function poorly, patients suffer with leg swelling, leg pain, leg ulcers, disability, and possible amputation. Therefore, it is important to restore blood flow out of the leg veins, back to the heart. Part of doing this successfully requires restoring the function of the venous valves,” said Gagne.

Cook Medical states that CVI affects around 1 in 20 adults. To address this need, the company and Cook Advanced Technologies developed a valve that functions similar to the way the veins naturally work. The artificial valve is a novel proprietary design that mimics native venous valves.

“After extensive ultrasonic and venographic evaluation of venous anatomy, we placed the Cook Medical venous valve in the leg vein. The deployment took a few minutes and the patient had local anaesthesia. It was a team effort to manage this complex case, resulting in the first clinical use of this venous valve,” said Alviar.

The clinical trial will continue to evaluate safety, efficacy, wound healing, leg pain, and disability levels over the next five years.

Five-year results of the LEOPARD trial published in the Journal of Vascular Surgery

Endologix has announced the online publication of the final five-year results of the LEOPARD trial in the Journal of Vascular Surgery (JVS). The study’s findings showed that there was no significant difference in aneurysm-

“The publication of these final five-year results in JVS reinforces the performance of our AFX2 endovascular AAA [abdominal aortic aneurysm] system in the treatment of patients with [AAAs],” said Matt Thompson, president and CEO of Endologix. “We are proud to have conducted the first randomised controlled trial comparing commercially available endografts, and we remain committed to providing the highest quality clinical evidence that underpins our life-changing vascular therapies. Importantly, the comparable performance results from the LEOPARD study between AFX/AFX2 and other endografts align with a recent publication that was authored on behalf of the Society for Vascular Surgery’s Patient Safety Organization and used linked registry claims data.”

LEOPARD was a prospective, randomised, multicentre trial that enrolled 455 patients across 56 US centres. Two-hundred and thirty-five patients were included in the AFX/ AFX2 arm and 220 patients in the comparator arm.

The primary endpoint was freedom from aneurysm-related complications (ARC), a composite endpoint consisting of perioperative death, aneurysm rupture, conversion to open surgical repair, postoperative endoleaks, endograft migration, aneurysm enlargement, endograft limb occlusion, and device- or aneurysmrelated reintervention.

The results presented included:

„ A rate of freedom from ARC at five years that was:

– 63.8% in AFX/ AFX2 device cohort

– 55.5% in comparator endografts

„ There was no clinically significant difference in aneurysm-related mortality, all-cause mortality, rupture, secondary interventions, and type 1 and type 3 endoleaks between the two cohorts

– The type 3 endoleak rate for the AFX/AFX2 device cohort was 1.5% at five years and was not statistically different from the comparator devices

– The type 2 endoleak rate reached a statistically significant lower rate at 21.2% at five years for the AFX2

First patient

enrolled in PROWL registry study using Pounce thrombectomy system

Surmodics has announced enrolment of the first patient in PROWL, the Pounce thrombectomy system retrospective registry. PROWL is an open-label, retrospective, multicentre US registry of the Pounce system for the nonsurgical removal of emboli and thrombi in the peripheral arterial vasculature.

The registry will collect real-world efficacy and safety outcomes data for endovascular interventions using the Pounce system for up to 500 patients at up to 30 sites. Sean Lyden, chairman of the Department of Vascular Surgery, Cleveland Clinic (Cleveland, USA) and Joseph Campbell, interventional cardiologist, OhioHealth (Columbus, USA) are national co-principal investigators. The first site to enrol a patient in the registry study was Baton Rouge General Medical Center (Baton Rouge, USA).

“We are delighted to be the first site to enrol a patient in the PROWL registry,” said Joseph Griffin, vascular surgeon at the Vascular Specialty Center and Baton Rouge General Medical Center.

“In our experience, the Pounce system promptly removes peripheral arterial clot in a single treatment session while reducing the need for thrombolytic drugs and subsequent intensive care unit stays. We are eager to help track outcomes in this important study.”

“We have long needed better tools to help us resolve acute limb ischaemia in a simple and effective manner, without the use of multiple adjunctive treatments,” he added. “In this respect, our experience with the Pounce system has been quite positive.”

PROWL’s primary efficacy endpoint is procedural success, while the primary safety endpoint is the incidence of device-related major adverse events in the 30 days post-procedure.

“Acute limb ischaemia from arteries blocked by thrombus or embolus is an urgent threat to both limb and life,” said Gary Maharaj, president and CEO of Surmodics. “With hospitals increasingly short on staff and beds, physicians need a simple and effective tool that lets them restore arterial flow right on the table without resorting to time-consuming and costly adjunctive treatments. We are confident the PROWL registry will demonstrate these exceptional attributes of the Pounce system in real-world clinical practice.”

Results from PROMISE II pivotal trial suggest “transformational value” of deep vein arterialisation in no-option CLTI patients

Results from the PROMISE II pivotal trial investigating transcatheter arterialisation of the deep veins using the LimFlow system in so-called no-option chronic limb-threatening ischaemia (CLTI) patients were recently published in the New England Journal of Medicine (NEJM).

The publication confirmed an amputation-free survival rate of 66% at six months, which exceeded the trial’s primary endpoint target of 54%, as reported by co-principal investigator Daniel Clair (Vanderbilt University, Nashville, USA) at the 2022 Vascular Interventional Advances (VIVA) meeting (31 October–3 November, Las Vegas, USA).

PROMISE II—multicentre, prospective and single-arm—included 105 patients with CLTI. The pool bore a median age of 70, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino.

Transcatheter arterialisation of the deep veins was performed successfully in 104 patients (99.0%), the researchers report in NEJM. At six months, 66.1% of the patients had amputation-free survival. “Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis),” they write. “Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported.”

Patients enrolled in PROMISE II “were representative of real-world patients,” including those with dialysisdependent chronic kidney disease (CKD) and Rutherford class 5 or 6 wounds—groups “routinely excluded” from vascular device studies, the trialists noted in the discussion section of their paper.

Prespecified subgroup analyses indicated a difference between the 19 patients with dialysis-dependent CKD—who had amputation-free survival of 36.8%—and the 86 patients who did not (72.7%), the authors report. Similarly, the mortality rates among these groups of patients were 36.2% (dialysis dependent) and 8.6%, they show.

“Results of a prespecified subgroup analysis were aligned with those of previously published outcomes indicating an increased risk of death after peripheral arterial revascularisation procedures among patients who were undergoing dialysis,” they write.

“Although the incidence of limb salvage was similar between patients who had dialysis-dependent CKD and those who did not, mortality appeared to be greater in the population with dialysis-dependent disease.