Second Round of Late-Breaking Clinical Trial Results Announced at VIVA22 – QNT Press Release

LAS VEGAS, Nov. 1, 2022 /PRNewswire/ — 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 second of three Late-Breaking Clinical Trials sessions at the VIVA22 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 summaries of this afternoon’s 6 late-breaking clinical trial presentations.

Three-Year Results of the GORE® VIABAHN® Stent Graft in the Superficial Femoral Artery for In-Stent Restenosis
Presented by Peter A. SoukasMD

The RELINE MAX study is the first report of long-term, 36-month outcomes of the postmarket approval study of the Gore VIABAHN endoprosthesis (Gore & Associates) for the treatment of bare-metal in-stent restenosis (ISR) in the superficial femoral artery (SFA).

RELINE MAX was a prospective, single-arm international study that enrolled patients at 23 sites from October 2015 to April 2018. Patients with ≥ 50% ISR or occlusion in the SFA, Rutherford category 2-5 disease, and ≥ 1 patent runoff vessel were eligible. The primary effectiveness endpoint was primary patency at 12 months. The primary safety endpoint was rate of device- or procedure-related serious adverse events (SAEs) at 30 days.

A total of 108 patients were enrolled in the study; 86 were included for analysis through 3 years (mean age, 70.9 ± 10.4 years; 48.8% female). Mean core lab–reported lesion length was 12.4 ± 6.92 cm (29.1% occluded lesions ); 10.5% of patients presented with chronic limb-threatening ischemia and 81.9% of lesions were Tosaka class II and III. Acute procedural success was 98.8%. Freedom from device- or procedure-related SAEs was 96.5% through 30 days. At 1 year, primary, primary-assisted, and secondary patency rates were 74.7%, 80.4%, and 89.4%, respectively. Freedom from target lesion revascularization was 84.8%, 74.6%, and 65.0% at 1, 2, and 3 years, respectively . Per core lab assessment, no major amputations or device fractures occurred through 3 years. At 3 years, 80.4% of patients had ≥ 1 Rutherford category improvement.

More recent studies from Japan using the study device in de novo SFA lesions suggest high primary patency rates with use of intravascular ultrasound (IVUS) to avoid oversizing the device by 20%. A prospective evaluation of stent grafting for the treatment of femoropopliteal ISR utilizing IVUS and best practices is needed to improve the long-term outcomes of patients with long, complex femoropopliteal ISR.

Cross-Seal™ IDE Trial: Prospective, Multi-Center, Single-Arm Study of the Cross-Seal™ Suture-Mediated Vascular Closure Device System
Presented by Prakash KrishnanMD

The objective of this prospective, multicenter, single-arm trial (NCT03756558) was to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device (VCD; Terumo Interventional Systems) in obtaining hemostasis at the target limb access site after interventional procedures using 8- to 18-F procedural sheaths.

The trial included patients undergoing transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty, or endovascular thoracic or infrarenal aortic aneurysm repair (TEVAR/EVAR) using 8- to 18-F sheath …

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