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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

NCT07397390 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2026-04-03

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DEVICE

DKutting LL scoring balloon angioplasty

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Dalian Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-17
Primary Completion
2026-12-30
Completion
2027-03-30
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07397390 on ClinicalTrials.gov