Trials / Enrolling By Invitation
Enrolling By InvitationNCT07397390
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
A Prospective, Single-Arm Observational Study on the Effectiveness and Safety of the DKutting® LL Balloon in VEssel Preparation for CALcified Lesions in Infra-inguinal Arteries, the DkuLL CALVEP Study.
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 58 (estimated)
- Sponsor
- The First Affiliated Hospital of Dalian Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2026-03-17
- Primary completion
- 2026-12-30
- Completion
- 2027-03-30
- First posted
- 2026-02-09
- Last updated
- 2026-04-03
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07397390. Inclusion in this directory is not an endorsement.