The VIVA Foundation, a not-for-profit organization dedicated to advancing vascular medicine through education and research, announced results from three Late-Breaking Clinical Trials presented this afternoon at VIVA 2026, held at Bellagio Las Vegas.
For 24 years, VIVA (Vascular InterVentional Advances) has set the benchmark for premier education and clinical excellence in peripheral vascular disease. Known for delivering the most up-to-date, practice-changing data, VIVA brings together the latest science, technological innovation, and international expertise.
9-Month Outcomes of the AGILITY Trial Iliac Cohort: A Prospective, Multicenter Study on Revello™, a Low-Profile Self-Expanding Covered Stent
Presented by Sean P. Lyden, MD
Background: AGILITY is a prospective, multicenter, single-arm IDE study to evaluate the safety and effectiveness of Revello™, a novel low-profile, self-expanding covered stent in patients with iliac artery lesions (NCT06111469).
Methods: The iliac cohort consisted of 120 iliac subjects across 28 international sites. The composite primary endpoint was defined as device and/or procedure-related death or myocardial infarction through 30 days, or clinically driven target lesion revascularization (CD-TLR), or target limb major amputation, or target lesion restenosis through 9 months and was evaluated against a performance goal (PG) of 19%. Secondary endpoints include technical and clinical success, freedom from CD-TLR, primary patency, and major adverse events (MAE).
Results: The iliac cohort had a mean age of 67.0 years, and 40.8% of the patients were female. The study included lesions with varied anatomical characteristics, TASC A (50.0%), TASC B (24.2%), TASC C (13.3%) and D (12.5%), occlusions (29.4%), involvement of the external iliac artery (51.7%), and moderate-to-severe calcification (49.6%). The primary binary composite endpoint was 3/108 (2.8%; 95% CI, 0.6%-7.9%; one-sided P<0.0001 versus PG 19%). Acute lesion-, procedural-, technical- and sustained clinical success rates were 100.0%, 97.5%, 99.3% and 95.5%, respectively. At 9 months, freedom from CD-TLR and TVR were both 98.3%, while primary patency was 97.2% at 9 months. MAE occurred in 1.7% of patients.
Conclusions: In the AGILITY IDE iliac cohort, treatment with Revello™, a self-expanding covered stent, was associated with favorable safety and clinical outcomes through 9 months, including achievement of the pre-specified PG for the primary endpoint.
PERFORMANCE II Stroke Rates Through 1 Year: A Deep Dive Into Ipsilateral and Contralateral Stroke Outcomes by Subgroups
Presented by William A. Gray, MD
The PERFORMANCE II (PII) pivotal trial enrolled 305 subjects at high risk for CEA, both symptomatic and asymptomatic, to assess the safety and efficacy of the Neuroguard Integrated Embolic Protection (Neuroguard IEP) system in carotid artery stenting (CAS) using dual filtration and a purpose-built carotid stent. At 30 days there were 4 strokes (all minor), with 1 additional minor stroke at 1 year, and very low rates of target lesion revascularization.
We evaluated the outcomes in PII high-risk CAS sub-groups: symptomatic, age >75 years, and significantly calcified lesions. Separately, any contralateral stroke events are assessed.
Because of the low event rate in PII, statistical power was limited. However, there were no differences in outcomes between symptomatic and asymptomatic subjects, or between subjects >75 years or <75 years.
When outcomes by site-reported calcification grade were analyzed, there was a trend toward worse outcomes in higher grades of lesion calcium. However, when core lab-controlled assessments of calcium grade were used instead (where 2/3 of the subjects had moderate or severe lesion calcium), there were no differences in outcomes by calcium grade.
Lastly, there were no contralateral strokes reported in PII. Prior analysis from 2007 suggested a nearly 1% incidence.
The authors note that historical comparators with subset assessments are problematic due to incomplete data, lack of core lab adjudication, variable calcium scoring.
In conclusion, this subset analysis demonstrated an overall very low event rate, limiting analytic power. There was no outcome differentiation by at-risk lesion or participant characteristics, and no contralateral strokes, consistent with changes in CAS over time, especially refined patient selection. Post-hoc calcification analysis demonstrates gap between site-reported and core laboratory adjudicated calcification, with potential effects on outcome assessment
The Neuroguard IEP with double filtration appears to be performing as designed to reduce stroke risk for patients across all at-risk subgroups.
Treating Chronic Limb Ischemia Patients With Atherothrombectomy: Early Real-World Evidence From the Rotarex Global XTRACT Registry
Presented by Prakash Krishnan, MD
The XTRACT Registry is a prospective, multi-site, international, single-arm, real-world study evaluating the safety and effectiveness of the Rotarex™ Rotational Excisional Atherectomy System in patients with PAD (NCT07016698). This post-market registry will enroll approximately 600 patients in two separate cohorts: acute limb ischemia (ALI) and chronic limb ischemia (ChLI). Primary endpoints include freedom from composite of device- and/or procedure-related perioperative (≤ 30 day) death, unplanned target limb major amputation (above the ankle), and clinically driven target lesion revascularization (CD-TLR) at 30 days post-index procedure, and procedural success defined as the rate of successful revascularization of target lesion (residual stenosis/thrombus ≤30%) following the index procedure. Technical success is defined as reduction of residual stenosis and the successful creation of an optimal working channel allowing adjunctive therapies.
A total of 102 ChLI patients from nine investigational sites have been treated with Rotarex™ from Sept 2025 to June 2026, with enrollment ongoing. Subjects had a mean age of 69.7 years and 42.2% were female. The majority of subjects were Rutherford category 3 (37.3%) or 4 (34.3%). Over 20% of the patients had ≥ 2 target lesions treated with Rotarex™ (total of 130 lesions treated). The mean lesion length was 126.5mm, 54.6% de novo, and 26.9% in-stent restenosis, with 80.0% located in the SFA and 30.0% located in the popliteal artery. All 102 subjects had adjunctive procedures following Rotarex™, of which 18.5% had DCB and 91.5% had POBA. Technical success was 89.2%, with a low rate of device related distal embolization (0.98%), and 0% device related major flow limiting dissections. Primary safety, freedom from composite of device and/or procedural related complications through 30 days was 98.0%.
In this early interim analysis of the XTRACT Registry, treatment with the Rotarex™ system demonstrated high technical success and a low incidence of safety-related events (distal embolization and dissection) in a real-world PAD population. Ongoing enrollment and longer-term follow-up will further define outcomes across patient subgroups and lesion types.
About the VIVA Foundation
The VIVA Foundation is a nonprofit organization dedicated to advancing vascular medicine through education and research. Bringing together experts in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery, the Foundation provides multidisciplinary education designed to improve patient care and advance innovative therapies for vascular disease worldwide.
To learn more about the VIVA Foundation, visit https://viva-foundation.org/.
Media personnel should contact press@viva-foundation.org with questions.
