Utility of a novel high pressure non-compliant balloon for tibial atherosclerotic lesions in Asian patients with chronic limb threatening ischaemia

VASA. Zeitschrift für Gefässkrankheiten
Tjun Yip TangBryan P Y Yan

Abstract

Background: The aim was to evaluate the safety and efficacy of a high pressure, non-compliant balloon in the treatment of infrapopliteal occlusive disease in Asian patients with chronic limb threatening ischaemia (CLTI) from Singapore. Patients and methods: Prospective, multi-centre, single arm, non-randomized study. Immediate technical success, 6-month primary vessel patency (determined by Duplex ultrasonography), limb salvage, one-year clinically driven target lesion re-intervention (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest. Results: 86 patients (63% males, mean age 68.9 ± 9.9 years) were enrolled over a 15-month period. Diabetes mellitus (DM) and end-stage renal failure (ESRF) were present in 94% and 38% of patients respectively. All had some degree of tissue loss at baseline (Rutherford scale 5 and 6 = 91% and 9% respectively). Of the 86 legs, 72% had 3 crural vessel disease and 84% had moderate/severe vessel wall calcification. 90% had > = 1 TASC D tibial lesion. Acute technical success was 89%. One month mortality was 3.5% and one-year freedom from TLR was 91%. 6-month tibial patency was 73%. 54/66 (82%) patients had at least one target treated tibial artery open at 6 months. A lower...Continue Reading

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Citations

Apr 13, 2021·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Tjun Yip TangTze Tec Chong
Jun 1, 2021·International Angiology : a Journal of the International Union of Angiology·Tjun Y TangChuo R Leong

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Methods Mentioned

BETA
amputation
dissections
dissection

Clinical Trials Mentioned

NCT04071782

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