Angioplasty, Calcifications, Vascular, Cutting Balloon Angioplasty, Femoral Artery Stenosis, Infrapopliteal Arterial Occlusive Disease, Intravascular Imaging Device, Peripheral Artery Disease
Conditions
Keywords
Peripheral Arterial Disease, Femoropopliteal Artery, Infrapopliteal Artery, Calcified Lesions, Scoring Balloon, Angioplasty, Vessel Preparation, Intravascular Ultrasound (IVUS), Observational Study
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
Interventions
DEVICEDKutting 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
Sponsors
The First Affiliated Hospital of Dalian Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary effectiveness outcome | immediately after the intervention | 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). |
| primary safety outcome | 1 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency Rate at 30 days | 1 month | Freedom from clinically driven target lesion revascularization (CD-TLR) and a peak systolic velocity ratio (PSVR) of \<2.4 on duplex ultrasound. |
| Primary Patency Rate at 6 months | 6 months | Freedom from clinically driven target lesion revascularization (CD-TLR) and a peak systolic velocity ratio (PSVR) of \<2.4 on duplex ultrasound. |
| Incidence of Clinically Driven Target Lesion Revascularization (CD-TLR) at 6 months | 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. |
| Change in Rutherford Classification at 1 month post-procedure | 1 month | The proportion of patients showing an improvement of at least one category in the Rutherford Classification. |
| Intraoperative Complication Rate Related to Percutaneous Transluminal Angioplasty (PTA) | immediately after the intervention | 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 |
| ΔMLA (Change in Minimum Lumen Area) | immediately after the intervention | 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. |
| ΔCalcification Burden Improvement | immediately after the intervention | 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. |
Countries
China
Outcome results
None listed