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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

Study acronym: DkuLL CALVEP
StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Not Yet Recruiting → Enrolling by Invitation
    • Start date changed from estimate of Feb 18, 2026 to Mar 17, 2026
    • Site contact updated
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07397390
Lead Sponsor The First Affiliated Hospital of Dalian Medical University
Conditions
(from sponsor)		 Femoral Artery Stenosis, Angioplasty, Cutting Balloon Angioplasty, Calcifications, Vascular, Intravascular Imaging Device, Peripheral Artery Disease, Infrapopliteal Arterial Occlusive Disease
Related terms Peripheral Arterial Disease, Vascular Calcification
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov