The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, today announced results from the second round of Late-Breaking Clinical Trials presented at VIVA 2025, held at Wynn Las Vegas.
VIVA (Vascular InterVentional Advances) is an annual vascular education symposium that brings together a global, multispecialty faculty to present the latest research and clinical data. The program is attended by interventional cardiologists, interventional radiologists, vascular surgeons, and specialists in endovascular medicine, providing unparalleled access to cutting-edge advances in vascular care.
Prospective, Multicenter Evaluation of Transcarotid Artery Revascularization (TCAR) in Standard-Risk Patients: 1-Year Outcomes of the ROADSTER 3 Study
Presented by: Meghan Dermody, MD
ROADSTER 3 was designed to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) using the ENROUTE stent in conjunction with the ENROUTE neuroprotection system (Boston Scientific) to treat standard-surgical-risk patients with extracranial internal carotid artery disease. In contrast to prior surveillance-based studies of TCAR procedures, ROADSTER 3 is prospective, with independent event adjudication and independent neurological assessments.
ROADSTER 3 is a prospective, multicenter, single-arm postapproval study. Patients aged <80 years without anatomic or physiologic high surgical risk factors were included. Between 2022 and 2024, 344 patients were prospectively enrolled at 48 sites in the United States. Of enrolled patients, 42.7% were female and 16.3% were symptomatic. The per-protocol population, which included 319 patients due to 25 patients with major protocol deviations, was the primary analysis population as required by the Food and Drug Administration. The primary endpoint was the hierarchical composite incidence of major adverse events defined as stroke, death, or myocardial infarction within 30 days and ipsilateral stroke from 31 to 365 days post procedure.
For the per-protocol population, the 30-day stroke/death/myocardial infarction rate was 0.6% (2/319). Two ipsilateral strokes occurred from 31 to 365 days post procedure (0.7%). The composite incidence of death, stroke, or myocardial infarction through 30 days and ipsilateral stroke from 31 to 365 days post procedure was 1.3% (4/305) for the per-protocol population. For the entire study population, there were strokes in 5 patients (1.5%; 5/329) with no instances of death or myocardial infarction within 30 days.
The primary results of the ROADSTER 3 study demonstrate safety and effectiveness of TCAR in the standard-risk population, based on prospective data with independent event adjudication and independent neurological assessment.
Potential for Sustained Abdominal Aortic Aneurysm Growth Stabilization After a Single Intra-Aortic Administration of Pentagalloylglucose: Clinical Evidence From a Phase I Study With the Nectero EAST® System
Presented by: Ramon L. Varcoe, MBBS, PhD
Study Design: Prospective, multicenter, OUS study of 46 patients with AAAs <5.5 cm in diameter. Patients were administered a one-time treatment of pentagalloylglucose (PGG) solution intra-arterially to the aneurysm with a weeping balloon over 3 minutes under infrarenal occlusion. Follow-up computed tomography angiography (CTA) was performed at 1, 2, and 3 years. Changes in maximum orthogonal AAA sac diameter were assessed by an independent core laboratory to determine growth. Annualized PGG-treated AAA growth rates were compared to expected natural history per Brady et al.1
Results: First-in-human (FIH) study results suggest an acceptable safety profile following local treatment with PGG solution. Mean baseline AAA maximum diameter was 42.7 mm (n=45). One-year follow-up data is available on the complete cohort of patients (n=44); there was a mean 70% reduction in AAA diameter growth from expected natural history. Complete follow-up data on the initial 21 patients is available (Phase Ia); average growth through 2 and 3 years was 2.5 mm (n=17) and 3.9 mm (n=14), respectively, representing a reduction from expected natural history growth of 56% through 2 years and 55% through 3 years.
Conclusions: A single administration of PGG may result in a sustained reduction of growth compared to expected natural history of small- to medium-sized AAAs and has the potential to significantly extend the time to OSR or EVAR conversion. These initial findings support further investigation in a randomized, controlled trial now underway.
1 Brady AR, et al. Abdominal aortic aneurysm expansion risk factors and time intervals for surveillance.
Circulation. 2004;110(1):16-21.
AGILITY: A Prospective, Multi-Center Evaluation of the BD Low Profile Vascular Covered Stent (Revello) in Peripheral Artery Disease
Presented by: Sean P. Lyden, MD
The AGILITY study is a global, prospective, multicenter, single-arm investigational device exemption (IDE) trial evaluating the Revello™ Vascular Covered Stent for treating complex peripheral artery disease (PAD) in the common/external iliac and superficial femoral artery (SFA)/ proximal popliteal artery (PPA). AGILITY will enroll 341 subjects across 45 global sites, divided into iliac (n = 118) and SFA/PPA (n = 223) cohorts. Each cohort’s primary endpoint is assessed against literature-based performance goals. The iliac cohort’s composite endpoint includes device/ procedure-related death or MI (30 days), CD-TLR, major amputation, or restenosis (9 months), while the SFA/PPA cohort focuses on freedom from major adverse events (30 days) and primary patency (12 months). Secondary endpoints include Rutherford category improvement, patency durability, quality of life (WOQ), and procedural success. Follow-up occurs at discharge, 30 days, 6 months (SFA/PPA only), 9 months (iliac only), and 12, 24, and 36 months. Initial results from 60 iliac patients show a mean age of 67 years (range: 48-88), 61.7% male. Lesions were 70% stenosed and 30% occluded, with 33.3% showing severe calcification. Mean lesion length was 45.7 mm (range: 10-170 mm), and angiographic classification included TASC C (16.7%) and D (11.7%) (NCT06111469).
About the VIVA Foundation
The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by the VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide.
