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 fourth and final 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.
Two-Year Clinical Outcomes From the Randomized-Controlled Arm of the WAVE Trial
Presented by: David J. Dexter, MD
Purpose: To summarize 24-month clinical outcomes following use of a novel cell-impermeable endoprosthesis (CIE) vs percutaneous transluminal angioplasty (PTA) to treat venous outflow obstructions in patients on hemodialysis.
Materials and Methods: A prospective, multicenter, international trial was conducted across 43 international centers. The randomized arm of the study included patients with venous outflow obstruction(s) in their arteriovenous fistula who were randomized 1:1 to treatment with the CIE or PTA. The primary safety endpoint was the proportion of patients without any localized or systemic safety events. The primary efficacy endpoint was the proportion of patients who achieved target lesion primary patency (TLPP) at 6 months. Access circuit primary patency (ACPP) was an additional efficacy measure of interest.
Results: A total of 245 patients were analyzed (CIE: n = 122; PTA: n = 123). The primary safety outcomes through 30 days were comparable for both interventions (CIE: 96.6%; PTA: 95.0%; noninferiority P < .0001). Device-related events were lower for the CIE vs PTA (2.9% vs 9.5%, P = .049). No significant differences in the proportion of patients experiencing serious adverse events were observed. Across all time points evaluated, TLPP has been significantly higher with the CIE vs PTA (6 months: 89.8% vs 62.8%, P < .0001; 12 months: 70.1% vs 41.6%, P < .0001). The CIE was associated with significantly higher ACPP at 6 months (72.6% vs 57.9%, P = .015) and 12 months (58.1% vs 34.4%, P = .0003). Findings at 24 months are pending.
Conclusions: The ability to prolong vascular access has important implications for physicians and patients. The 24-month outcomes from this study will address questions regarding the durability of clinical benefits associated with the CIE vs PTA.
Wearable, Noninvasive Therapeutic Ultrasound for Treatment of CLTI: A Sham-Controlled Randomized Controlled Trial
Presented by: Mahmood Razavi, MD
A randomized, double-blinded, crossover design clinical trial enrolled 29 Rutherford class 4-5 patients in 2:1 ratio to treatment with a wearable phased array of TUS transducers engineered to sonicate the posterior and anterior tibial arteries (and their collaterals) at the level of the calf vs sham therapy with an acoustically inert array of transducers. Patients underwent 30 treatments (active or sham) of 90 minutes with follow-up for 2 months after which active patients received another 15 treatments with 2-month follow-up to assess chronic changes. Endpoints included changes in Rutherford class, ankle- and toe-brachial indices (ABI/TBI), pedal tissue oxygenation (StO2) by spatial frequency domain imaging (Clarifi; Modulim), transcutaneous oximetry (TcPO2), and quantitative wound assessment. Per-protocol data are reported on the 23 patients who completed all TUS sessions and 9 patients who completed all sham sessions, and they were analyzed by paired t-tests and Chi-square analysis.
At baseline, 78% of patients were Rutherford class 4 and 22% were Rutherford class 5. After active TUS, 82% of patients were Rutherford classes 1-3 compared with only 22% of sham patients (P = .0012). TBI improved by 25% from 0.36 +/- 0.04 to 0.45 +/- 0.08 (P = .21) under active TUS with similar increases in toe pressure. Sham patients had no improvement in either TBI or toe pressure. Clarifi demonstrated a 24% increase in tissue oxygenation in the active TUS group compared with 6% decrease after sham (P = .15). There were no significant changes in TcPO2 in either group. Of the 5 patients with wounds undergoing active TUS, 3 demonstrated full wound healing and one had a reduction in wound size for a mean reduction in wound diameter of 71% from 28 +/- 10 to 8 +/- 11 mm. The 2 patients with wounds in the sham group had no improvement. Therapy was well tolerated by patients, and there were no serious adverse events.
Noninvasive TUS for CLTI patients was safe, well tolerated, and demonstrated improvements in Rutherford class and wound healing. Future studies will evaluate the potential for even longer-term therapy to increase efficacy.
36-Month Performance of a Sirolimus-Eluting Balloon in Diabetic and Nondiabetic Patients With Femoropopliteal Artery Disease From the SELUTION SFA Japan Study
Presented by: Ehrin Armstrong, MD
Background: Among patients with peripheral artery disease (PAD), those with diabetes mellitus (DM) represent a particularly high-risk group due to more aggressive atherosclerosis, smaller vessel diameters, and a higher risk for restenosis following endovascular interventions. Pathophysiologic differences and altered healing responses may lead to distinct outcomes between diabetic and nondiabetic patients.
Aim: The SELUTION SLR™ drug-eluting balloon (DEB) delivers sirolimus in a controlled, sustained manner, offering a favorable safety profile and a potential alternative to paclitaxel-based devices. This 36-month stratified analysis evaluates the performance of SELUTION SLR™ DEB in a Japanese population with and without DM.
Methods: The SELUTION SFA Japan (MDK-1901) study is a prospective, multicenter, single- arm trial that enrolled 134 patients across 13 Japanese sites. The primary endpoint was target lesion primary patency at 12 months. Patients were followed for 36 months; secondary endpoints included target lesion revascularization (TLR), target vessel revascularization (TVR), thrombosis, and mortality.
Results: Of 134 enrolled patients, 79 (59%) had DM and 55 (41%) did not. At 36 months, Kaplan–Meier estimates showed freedom from TLR of 93.5% in the DM group and 94.3% in the non-DM group. Primary patency was 83.0% in DM patients vs 79.3% in non-DM patients. All-cause mortality was 2.8% in the DM group and 5.9% in the non-DM group.
Conclusion: SELUTION SFA Japan is the first study to assess SELUTION SLR™ DEB in a Japanese population. The 36-month data demonstrate durable efficacy and a favorable safety profile in femoropopliteal disease, with comparable outcomes in patients with and without DM. These findings strengthen the evidence for SELUTION SLR™ DEB as a long-term therapeutic option in PAD, highlighting its potential to address the needs of high-risk diabetic subgroups.
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.
To learn more about the VIVA Foundation, visit https://viva-foundation.org/.
