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

Conditions

• Angioplasty
• Calcifications, Vascular
• Cutting Balloon Angioplasty
• Femoral Artery Stenosis
• Infrapopliteal Arterial Occlusive Disease
• Intravascular Imaging Device
• Peripheral Artery Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• DKutting LL scoring balloon angioplasty — DEVICE
  Following the detection of calcified lesions by Intravascular Ultrasound (IVUS), and aided by its accurate measurements of lesion diameter and length, percutaneous transluminal angioplasty (PTA) was performed using the DKutting LL scoring balloon

Study Details

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

Key Dates

First listed

Feb 9, 2026

Start date

Mar 17, 2026

Status verified

Apr 2026

Primary completion

Dec 30, 2026

Completion

Mar 30, 2027

Study Design

Enrollment

58 participants (estimated)

Arms

• Arm: Dkutting LL treatment group
  IVUS facilitated DKutting LL angioplasty

Primary Outcome Measure

primary effectiveness outcome [ Time Frame: immediately after the intervention ]

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