an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloo… (NCT07397390) | Clinical Trial Compass
By InvitationNot Applicable
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
China58 participantsStarted 2026-03-17
Plain-language 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
Who can participate
Age range18 Years – 85 Years
SexALL
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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 expectanc…
What they're measuring
1
primary effectiveness outcome
Timeframe: immediately after the intervention
2
primary safety outcome
Timeframe: 1 month
Trial details
NCT IDNCT07397390
SponsorThe First Affiliated Hospital of Dalian Medical University