DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis (NCT05608655) | Clinical Trial Compass
CompletedNot Applicable
DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis
China188 participantsStarted 2022-12-27
Plain-language summary
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-80 year-old male \& non-pregnant female
* Patients with Arteriosclerosis Obliterans of Lower Extremities, including stenosis or osculation in femoropopliteal artery.
* Rutherford clinical category-Becker class: 2 to 5
* Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study.
* Digital subtraction angiography (DSA) shows femoropopliteal artery stenosis above 70%, appropriate for treatment with balloon angioplasty
* Reference vessel diameter from 2.5 to 7mm; Total length of lesion is less than 200mm; Total length of osculation lesion is less than 100mm
* Only one target lesion needs to be Treated. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. The number non-target lesions are limited to maximum 3.
Exclusion Criteria:
* Acute or sub-acute thrombosis exist in target lesion
* Severe calcified lesion (PACSS Grading 4)
* Guidewire cannot cross target lesion
* Amputation planned within 30 days
* In-stent restenosis
* Flow-limiting dissection (NHLBI grading: D-F) occurred in target lesion by pre-dilation
* No other lumen-reduction devices (such as: cutting balloon, dual-wire balloon, Hawk, ELCA etc.) are treated before or after test/control group treatment.
* Before test/control group tr…