Brought to you by:
When RCTs are essential for novel vascular access device regulation
As part of a 2024 VEITHsymposium (New York City; Nov. 19–23) debate, Robert E Lee, MD, a medical officer recently retired from the Food and Drug Administration (FDA), presented an argument in favor of when the use of randomized controlled…
Exploring the effectiveness of Topical Wound Oxygen therapy in diabetic foot and venous leg ulcers: ‘A new, different functionality that penetrates the wound’
This advertorial is sponsored by AOTI. Until about a decade and a half ago, vascular surgeon Alisha Oropallo, MD, could be counted among the skeptics. Back then, she says, topical wound oxygen therapy for nonhealing vascular wounds did not have…
AAA and complex repair: ‘We need more evidence,’ says UChicago chief
A randomized controlled trial (RCT) of open repair versus endovascular aneurysm repair (EVAR) for the treatment of abdominal aortic aneurysms (AAAs), as well as head-to-head trials for additional information on EVAR and complex repairs, are warranted. This was the main…
Equivalency to clinical practice ‘varies considerably’ across recent carotid intervention trials
The transferability to real-world clinical practice of contemporary randomized controlled trials (RCTs) investigating carotid artery stenosis interventions “varies considerably,” according to a recent analysis published in the European Journal of Vascular and Endovascular Surgery (EJVES) by senior author Hans-Henning Eckstein,…
Clinical outcomes of the ClotTriever system in DVT set to be evaluated in RCT
Inari Medical has announced planned enrollment of the DEFIANCE randomized controlled trial (RCT), which is designed to compare the clinical outcomes of patients with iliofemoral deep vein thrombosis (DVT) treated with the ClotTriever system versus anticoagulation only. The trial will enroll 300 patients…
Biomarkers of heart failure show early reversal with catheter thrombolysis compared to anticoagulation alone in a secondary analysis of the SUNSET sPE trial
In a secondary analysis of the SUNSET sPE randomized control trial, lead investigator Efthymios Avgerinos, MD, of the division of vascular surgery, University of Pittsburgh Medical Centre, Pittsburgh, Pennsylvania, and colleagues found differences in biomarker levels in response to treatment…
Interview: Combating the problem of spin, or overinterpretation, in RCTs
The presence of spin, or overinterpretation, in scientific papers that ultimately demonstrate statistically insignificant findings had been gnawing away at Thomas Forbes, MD, for quite some time. The practice, the University of Toronto vascular chair reflects, is by no means…
Canadian Vascular: Spin in RCTs
A large proportion of statistically nonsignificant randomized controlled trials (RCTs) yielded interpretations that were inconsistent with their results, according to an analysis of 31 manuscripts covering research comparing carotid endarterectomy (CEA) to carotid artery stenting (CAS) for carotid stenosis and…
MicroStent to treat PAD below the knee receives FDA breakthrough device designation
Micro Medical Solutions (MMS) recently revealed Food and Drug Administration (FDA) breakthrough device designation for its MicroStent vascular stent. This novel technology is designed to achieve and maintain vessel patency, enhance wound treatment and improve quality of life and blood…