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 | Not Yet Recruiting FDA Device

• 2 other identifiers: PJ-KS-KY-2025-940(X)20251012
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Peripheral Arterial Disease; Femoropopliteal Artery; Infrapopliteal Artery; Calcified Lesions; Scoring Balloon; Angioplasty; Vessel Preparation; Intravascular Ultrasound (IVUS); Observational Study

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Primary Patency Rate at 30 days

  1 month

• Primary Patency Rate at 6 months

  6 months

• Incidence of Clinically Driven Target Lesion Revascularization (CD-TLR) at 6 months

  6 months

• Change in Rutherford Classification at 1 month post-procedure

  1 month

• Intraoperative Complication Rate Related to Percutaneous Transluminal Angioplasty (PTA)

  immediately after the intervention

Study Arms (1)

Dkutting LL treatment group

IVUS facilitated DKutting LL angioplasty

Device: DKutting LL scoring balloon angioplasty

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

Dkutting LL treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

MeSH Terms

Conditions

Vascular Calcification; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

donghua ji, Medical Doctor

CONTACT

0411-83635963; nickji@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Chief Physician, The First Affiliated Hospital of Dalian Medical University

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 9, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

CN (1)