November 1, 2023

Third Round of Late-Breaking Clinical Trial Results Announced at VIVA23

The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the results for the third of four Late-Breaking Clinical Trial sessions at the VIVA23 conference, hosted at Wynn Las Vegas.

VIVA (Vascular InterVentional Advances) is an annual vascular education symposium that brings together a global, multispecialty faculty to present a variety of talks and live case presentations from clinical centers around the world. Attendees include an audience of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists. Below are highlights of this morning’s 5 late-breaking clinical trial presentations.

A Multicenter Trial Evaluation of the Neuroguard Carotid Artery Stent System With Integrated Embolic Protection: 30-Day and 1-year Outcomes of PERFORMANCE II
Presented by: William A. Gray, MD

The PERFORMANCE II study is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Neuroguard IEP 3-in-1 carotid stent and postdilation balloon system with integrated embolic protection (Contego Medical, Inc.) for the treatment of carotid artery stenosis in patients at elevated risk for adverse events following carotid endarterectomy. A total of 305 patients were enrolled at 40 sites in the United States and Europe. The study’s primary endpoint is the 30-day rate of major adverse events, defined as death, all stroke, and myocardial infarction within 30 days of the index procedure, plus ipsilateral stroke between day 31 and 1 year. Events were adjudicated by an independent clinical events committee, and angiograms and duplex ultrasounds were evaluated by an independent core lab. Of the 305 patients enrolled, the mean age was 70, and 20% were symptomatic. 230 (75%) patients had physiologic high-risk criteria, and 75 (25%) patients had anatomic high-risk criteria. The mean baseline angiographic stenosis was 85%, and 34% of lesions were severely calcified. At 30 days, the all-stroke rate was 1.31% (4 patients) and 0.98% (3 patients) in an intention-to-treat and per-protocol analysis, respectively. There were no major strokes, no contralateral strokes, one (0.3%) death (cardiovascular), and two (0.7%) non–ST-segment elevation myocardial infarctions through 30-day follow-up. Among asymptomatic patients, the 30-day stroke rate was 0.81% (2 patients). There was one (0.37%) minor ipsilateral stroke between day 31 and 1 year. There were no major strokes and no neurological deaths at 1 year. Target lesion revascularization through 1 year was 1.47% (4 patients). These 1-year outcomes of the PERFORMANCE II study demonstrate the safety and durability of the Neuroguard carotid stent system in a high-surgical-risk patient population and are the lowest event rates ever reported in an adequately powered, multicenter trial of any type of carotid revascularization, regardless of patient risk.

Acute Clinical and 90-Day Functional Outcomes in Pulmonary Embolism Patients Treated With Computer Assisted Vacuum Thrombectomy: Interim Analysis of the STRIKE-PE Study
Presented by: Ido Weinberg, MD

The STRIKE-PE study is evaluating real-world safety, performance, and long-term quality-of-life outcomes of computer assisted vacuum thrombectomy (CAVT) with the Indigo Aspiration System (Penumbra, Inc.) for the treatment of pulmonary embolism (PE). This prospective, international, multicenter study will enroll 600 patients with acute PE symptoms of ≤ 14 days and a right ventricular/left ventricular (RV/LV) ratio ≥ 0.9. Primary endpoints are the change in RV/LV ratio from baseline to 48 hours postprocedure and the incidence of major adverse events (MAEs) at 48 hours. Secondary endpoints include functional outcome measures. We report acute clinical and 90-day functional outcomes from an interim analysis.

This interim analysis included 150 patients (mean age, 61.3 years; 54.7% male; 5.3% with high-risk PE; 94.7% with intermediate-risk PE). Patients presented with high thrombus burden (modified Miller score ≥ 12) in 80.7% of cases.

Mean RV/LV ratio significantly decreased from 1.39 at baseline to 1.01 at 48 hours postthrombectomy (∆ 25.7%; P < .0001). Four (2.7%) patients experienced an MAE(s) within 48 hours. From baseline to 48 hours, the median clinical measures of heart rate and respiratory rate significantly decreased (P < .0001).

Borg dyspnea scale significantly improved from presentation to discharge and from presentation to 90-day follow-up (P < .0001). The 6-minute walk test distance significantly improved from discharge to 90-day follow-up (P < .0001). At 90-day follow-up, the New York Heart Association class proportion distribution was similar to that reported before the acute PE episode (P = .39).

STRIKE-PE interim results demonstrated a rapid, statistically significant improvement in RV/LV ratio and clinical measures while maintaining safety. At 90-day follow-up, treatment with CAVT with the Indigo aspiration system improved patients’ functional capacity by reducing dyspnea, increasing aerobic endurance, and improving cardiac symptoms.

30-Day Results From the C-Guardians Pivotal Trial of the CGuard™ Carotid Stent System
Presented by: D. Christopher Metzger, MD

C-GUARDIANS is a pivotal FDA investigational device exemption trial designed to evaluate safety and efficacy of the neuroprotective CGuard carotid stent (InspireMD, Inc.) in treating symptomatic and asymptomatic patients with carotid stenosis at a high risk for carotid endarterectomy (CEA).

From July 2021 to June 2023, 316 patients (mean age, 69.0 years; 31.6% female; 25% symptomatic) were prospectively enrolled in this single-arm carotid artery stenting study performed at 24 sites in the United States and the European Union. Procedures were performed utilizing the CGuard self-expanding stent, incorporating its patented woven Micronet mesh sleeve with small pore size of 150 µm designed to prevent plaque protrusion, utilizing approved embolic protection systems intraprocedurally. The primary endpoint is a composite of (1) incidence of major adverse events including death (all-cause mortality), any stroke, and myocardial infarction (DSMI) through 30 days post–index procedure and (2) ipsilateral stroke from day 31 to day 365 postprocedure. All events were adjudicated by a clinical events committee.

Intraprocedural cerebral protection utilized approved distal embolic filters or proximal embolic protection with flow cessation, or both. At 30 days, total major adverse events included a cumulative DSMI of 0.95% and a cumulative stroke and death rate of 0.95% (intent to treat, 0.95%; per protocol, 0.63%). Events included an in-hospital retinal stroke and a clinically silent troponin elevation, with two additional strokes at 30 days, including a patient who did not take dual antiplatelet therapy (protocol violation).

In the C-GUARDIANS pivotal trial, stenting with the CGuard carotid stent system in patients with obstructive carotid artery disease and at high risk for CEA had an overall stroke and death rate of 0.95% from the postprocedural interval to 30-day follow-up. The results support a potential “neuroprotective” effect of the CGuard stent from the procedure to 30-day follow-up.

Stellarex Vascular E-Registry (SAVER) Gender Subgroup Analysis
Presented by: Marianne Brodmann, MD

The Stellarex Vascular E-Registry (SAVER) was a multicenter, international, prospective registry designed to assess the safety and efficacy of the Stellarex drug-coated balloon (DCB; Philips) in femoral, popliteal, and/or infrapopliteal arteries in a broad, real-world, claudicant or critical limb ischemia patient population. Patients with Rutherford clinical classification 2 to 6 who were indicated for percutaneous transluminal angioplasty were enrolled.

The study was conducted with an individual DCB under normal clinical practice. The primary safety outcome was freedom from device- and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and clinically driven target lesion revascularization (CD-TLR) through 12 months. The primary efficacy outcome was freedom from CD-TLR at 12 months. Final 12-month outcomes of the above-the-knee (ATK) cohort were evaluated, and a subgroup analysis was performed to assess differences in outcomes according to gender. The SAVER ATK study demonstrated excellent key safety and efficacy endpoints at 12 months in a real-world population. There were no differences in outcomes when stratified into gender subgroups, demonstrating the strong safety and performance of the Stellarex DCB in both male and female patients.

Clinical Outcomes of Sirolimus-Coated Balloons Compared With Standard Balloon Angioplasty for Patients With Chronic Limb-Threatening Ischemia
Presented by: Edward Choke, MBBS, PhD

Sirolimus-coated balloons (SCBs) are a potential treatment option to improve outcomes for chronic limb-threatening ischemia (CLTI). However, clinical data for this novel treatment for CLTI are lacking. This study aimed to investigate the clinical outcomes of MagicTouch percutaneous transluminal angioplasty (PTA) SCB (Concept Medical, Inc.) compared to plain old balloon angioplasty (POBA) for patients with CLTI.

The HOPE registry is a single-center prospective registry of all CLTI patients. Prospective data captured included preprocedure baseline demographics, angioplasty details, and postprocedure clinical outcomes. Consecutive CLTI patients (n = 347) with Rutherford 4, 5, or 6 presentations and de novo infrainguinal artery disease between August 2018 and October 2021 were analyzed. Patients were excluded if they received paclitaxel devices, thrombolysis, or atherectomy devices. Patients were divided into two groups according to whether they received an SCB in addition to POBA (n = 141) or POBA alone (n = 206).

There were no statistically significant differences in the baseline demographics and lesion characteristics between the SCB and POBA groups. At 2 years, SCBs were associated with statistically significant higher freedom from clinically driven target lesion revascularization (75.2% vs 66.2%; hazard ratio [HR], 0.61; 95% CI, 0.38-0.97; P = .037), higher amputation-free survival (69.5% vs 55.1%; HR, 0.64; 95% CI, 0.46-0.88; P = .007), and higher survival (72.9% vs 64.3%; HR, 0.71; 95% CI, 0.50-0.99; P = .047). At 2 years, SCBs were also numerically but not statistically significantly associated with higher freedom from major amputation (93.5% vs 87.1%; HR, 0.63; 95% CI, 0.27-1.45; P = .274).

Compared to POBA alone, use of SCBs was associated with improved clinical outcomes at 2 years, and no early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCBs for treatment of CLTI.

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