Solaris Endovascular has announced an enrolment milestone in its DEScover clinical trial, assessing a sirolimus-eluting covered stent graft—Solaris DE—for the treatment of patients facing challenges with dialysis access dysfunction and peripheral arterial disease (PAD).
In a press release, Solaris Endovascular announced that trial enrolment is ahead of schedule and has successfully enrolled 42 patients out of the planned 120 patients to date.
The trial’s objective is to evaluate the safety and efficacy of the Solaris drug-eluting endovascular stent graft in patients with arteriovenous fistulae (AVF) and arteriovenous grafts (AVG). A total of 80 participants with AVF are randomised in a 1:1 ratio to receive either the Solaris DE device or standard balloon angioplasty, with a single-arm design for AVG patients (n=40) treated with Solaris DE.
The trial’s safety endpoints include the proportion of patients free from serious adverse events at 30 days, and efficacy will be determined by target lesion primary patency at six months.
With healthcare costs for end-stage kidney disease surpassing US$59 billion in 2020, effective dialysis access management is more critical than ever. Vascular access failures, particularly restenosis, remain unresolved. Solaris DE seeks to address this unmet clinical need by combining a mechanical barrier of the next-gen impermeable electrospinning PTFE with a biological barrier to block cell proliferation, the company’s press release adds.
Leonardo Harduin (Liv Care Centro Clínico, Niterói, Rio de Janeiro, Brazil), DEScover principal investigator, said: “The Solaris DE device, with its electrospinning PTFE coverage and sirolimus-eluting platform, is designed to effectively prevent restenosis and extend the functional duration of dialysis access for patients.”
Ziv J Haskal (University of Virginia School of Medicine, Charlottesville, USA), added: “Addressing edge stenosis is the next frontier in dialysis access care. This trial has the potential to significantly advance our treatment strategies.”
Marco Costa, chief medical and scientific officer of Solaris Endovascular, said: “I remember vividly the excitement and anticipation as a physician-scientist 26 years ago, when we treated the first patients with sirolimus-eluting coronary stents (Cypher). Similarly, reducing restenosis will not only improve outcomes but also expand the covered stent market from US$1.4 billion to an anticipated US$3 billion by 2030.”
