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 (DkuLL CALVEP)

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.

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Peripheral Artery Disease; Intravascular Imaging Device; Angioplasty; Femoral Artery Stenosis; Calcifications, Vascular; Cutting Balloon Angioplasty; Infrapopliteal Arterial Occlusive Disease
• Intervention / Treatment: Device: DKutting LL scoring balloon angioplasty

• Study Type: Observational
• Enrollment (Estimated): 58

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China
      • The First Affiliated Hospital of Dalian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

lower limb ischemia caused by calcified lesion in femoral-popliteal and infra-popliteal artery

Description

Inclusion Criteria:

• Age ≥ 18 years and ≤ 85 years.
• Clinical diagnosis of lower extremity atherosclerotic arterial disease, with a Rutherford Classification of Category 2-5.
• The patient has provided written informed consent.
• Life expectancy > 1 year.
• Confirmed by clinical and CTA examination: de novo or restenotic lesions after PTA in the femoropopliteal or infrapopliteal arteries, with no stent implantation within 2 cm of the target lesion. Stenosis ≥70% or chronic total occlusion (CTO).
• Lesion confirmed by CTA and color Doppler to have moderate to severe calcification (PACSS Grade 3-4). Lesion can be single or tandem, with a total length ≤150 mm. Reference vessel diameter near the target lesion ≥2 mm.
• Allowable location of the target lesion: ≥1 cm distal to the common femoral artery bifurcation, and up to 10 cm above the ankle.
• If the lesion is below-the-knee (BTK), the inflow vessels must have no non-target lesions, or any non-target lesions must be successfully treated with the current device without vascular complications.
• No serious vascular complications such as flow-limiting dissection occur after pre-dilation of the target lesion.
• Presence of at least one reconstructible infrapopliteal runoff vessel patent to the ankle.

Exclusion Criteria:

• Allergy to contrast media.
• Coagulopathy; severe hepatic insufficiency (ALT or AST > 3 times the upper limit of normal).
• Cardiac insufficiency (New York Heart Association Class III-IV).
• Life expectancy < 1 year.
• Acute cardiovascular events (e.g., acute myocardial infarction, stroke) within the past 3 months; active gastrointestinal bleeding affecting the use of anticoagulant/antiplatelet therapy.
• Previous stent implantation or bypass surgery in the target vessel.
• Acute/subacute limb ischemia or thrombotic lesions.
• Contraindications to anticoagulation or antiplatelet therapy.
• Failure to cross the lesion with a guidewire during the procedure; anticipation that the IVUS catheter or DKutting balloon will be unable to cross the lesion after pre-dilation.
• Intraoperative occurrence of severe complications requiring conversion to other treatment methods (e.g., bypass surgery).
• Pregnant or lactating women.
• Active infection at the intended treatment site; foot wounds reaching WIfI Stage 3, or ankle/foot ulcers primarily of non-ischemic etiology.
• Patient withdrawal of informed consent.
• Planned amputation.
• Planned use of adjunctive therapy devices (e.g., atherectomy, laser).
• Participation in another interventional drug/device clinical study for lower limb arteries where the primary endpoint has not been reached, or planned participation in such a study.
• Patient is bedridden or unable to walk.
• Presence of an aneurysm in the ipsilateral limb vasculature.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dkutting LL treatment group; IVUS facilitated DKutting LL angioplasty	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary effectiveness outcome	Technical Success Rate: Definition: Immediate post-procedural residual stenosis ≤30% after dilation with the Scoring Balloon Dilatation Catheter or a conventional balloon catheter, and without the occurrence of severe flow-limiting dissection (Grade D-F according to the National Heart, Lung, and Blood Institute (NHLBI) classification).	immediately after the intervention
primary safety outcome	Incidence of emergency target lesion revascularization, unplanned amputation above the ankle on the target side, or grade D or higher flow-limiting dissection or perforation requiring intervention	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency Rate at 30 days	Freedom from clinically driven target lesion revascularization (CD-TLR) and a peak systolic velocity ratio (PSVR) of <2.4 on duplex ultrasound.	1 month
Primary Patency Rate at 6 months	Freedom from clinically driven target lesion revascularization (CD-TLR) and a peak systolic velocity ratio (PSVR) of <2.4 on duplex ultrasound.	6 months
Incidence of Clinically Driven Target Lesion Revascularization (CD-TLR) at 6 months	The need for repeat revascularization in patients with clinical symptoms, including recurrent rest pain, worsening ulcer, or new foot ulcer. Revascularization methods include endarterectomy, bypass surgery, or repeat endovascular angioplasty.	6 months
Change in Rutherford Classification at 1 month post-procedure	The proportion of patients showing an improvement of at least one category in the Rutherford Classification.	1 month
Intraoperative Complication Rate Related to Percutaneous Transluminal Angioplasty (PTA)	Includes the occurrence of immediate flow-limiting dissection (NHLBI Grade A-F) after dilation with the Scoring Balloon Catheter, vessel perforation caused by PTA, and distal embolism caused by PTA	immediately after the intervention
ΔMLA (Change in Minimum Lumen Area)	Assessed by Intravascular Ultrasound (IVUS) to preliminarily evaluate the effectiveness of the DKutting balloon in vessel preparation for lower limb arterial calcified lesions, with the primary metric being the immediate post-procedural increase in MLA. Calculated as the difference in MLA measured by IVUS before and immediately after PTA.	immediately after the intervention
ΔCalcification Burden Improvement	Assessed by IVUS, measured as the change in the arc of continuous calcification in the vessel wall cross-section. Calculated as the difference in the arc of continuous calcification (differentiating between intimal and medial) measured by IVUS before and immediately after PTA.	immediately after the intervention

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Dalian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Observational Study; Angioplasty; Scoring Balloon; Peripheral Arterial Disease; Intravascular Ultrasound (IVUS); Calcified Lesions; Femoropopliteal Artery; Infrapopliteal Artery; Vessel Preparation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Calcium Metabolism Disorders; Calcinosis; Nutritional and Metabolic Diseases; Peripheral Arterial Disease; Vascular Calcification
• Other Study ID Numbers: PJ-KS-KY-2025-940(X); 20251012 (Other Identifier: The First Affiliated Hospital of Dalian Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No