VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, presents the data summary below in conjunction with our Late-Breaking Clinical Trials Livestream on June 25, 2020.
Presenter: Frank Vermassen, MD, PhD
To evaluate the long-term safety and effectiveness of the Eluvia Drug-Eluting Vascular Stent System for treating superficial femoral artery and/or proximal popliteal artery lesions >140 mm and ≤190 mm in length.
The Long Lesion Sub-study was a single-arm branch of the prospective, global IMPERIAL study including patients with lesions >140 mm in length who were treated with Eluvia. Primary patency, patient outcomes, and major adverse events have now been assessed through 24 months.
Fifty patients with mean lesion length 162.8 ± 34.7 mm were enrolled (40% with diabetes, 28% with severe calcification, 32% with occlusion). Overall, 24-month clinical follow-up was completed for 43 patients (2 died, 1 withdrew, 4 missed the visit). At 24 months, the freedom from clinically-driven target lesion revascularization rate was 86.7% (38/44) and the Kaplan-Meier estimate of primary patency was 77.2%. A total of 88.1% (37/42) of patients presented as Rutherford category 0 or 1 at 24 months and the same number demonstrated improvement of at least one category without the need for TLR.
Excellent vessel patency and a good safety profile were observed after 2 years in patients treated with Eluvia in the IMPERIAL Long Lesion sub-study, despite the lesion complexity. Clinical outcome improvements were sustained through 2 years.
About VIVA Physicians
VIVA Physicians, 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 VIVA Physicians 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 VIVA Physicians, visit www.vivaphysicians.org.
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