an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions

This is a prospective, single-center, single-arm, observational study. It plans to enroll 58 patients with moderate to severely calcified lesions in the femoropopliteal or infrapopliteal arteries. Participants will be treated with the Scoring Balloon Dilatation Catheter manufactured by DK Medtech (Suzhou) Co., Ltd. The study aims to evaluate the immediate technical success rate and the improvement in lumen area and calcification burden as assessed by IVUS following percutaneous transluminal angioplasty with the scoring balloon. Clinical follow-ups will be conducted at discharge (or within 7 days), 1 month, 3 months, and 6 months post-procedure to observe secondary endpoints including the incidence of clinically driven target lesion revascularization and changes in Rutherford classification

NCT Number	NCT07397390
Lead Sponsor	The First Affiliated Hospital of Dalian Medical University
Conditions	Femoral Artery Stenosis, Angioplasty, Cutting Balloon Angioplasty, Calcifications, Vascular, Intravascular Imaging Device, Peripheral Artery Disease, Infrapopliteal Arterial Occlusive Disease
Enrollment	58 participants
Start Date	2026-03-17
Primary Completion	2026-12-30 (estimated)
Study Completion	2027-03-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-03