An observational study in Femoral Artery Stenosis, Angioplasty and Cutting Balloon Angioplasty, sponsored by The First Affiliated Hospital of Dalian Medical University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by The First Affiliated Hospital of Dalian Medical University · Observational
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
82 studies on the registry are indexed under Vascular Calcification; 17 are open to participants now.
This study's planned enrollment of 58 is below the median of 80 across 23 observational studies indexed under Vascular Calcification.
Browse Vascular Calcification studies →The First Affiliated Hospital of Dalian Medical University is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
lower limb ischemia caused by calcified lesion in femoral-popliteal and infra-popliteal artery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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).
Time frame: 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
Time frame: 1 month
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: immediately after the intervention
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
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The First Affiliated Hospital of Dalian Medical University