Clinical trial NCT05608655: DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Artery Stenosis
Popliteal Artery Stenosis
Keywords: PTA Scoring Balloon
Optimal Balloon Angioplasty
Lead sponsor: DK Medical Technology (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-08
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate achievement of optimal PTA dilatation. A total of 188 patients will be enrolled from 14 sites in China. All patients enrolled will be assigned to the test group (DKutting LL balloon, n=94) and the control group (Chocolate balloon, n=94) with randomized allocation ratio of 1:1.

Primary endpoint is percentage of PTA cases in which \<30% diameter stenosis without a flow limiting dissection is achieved. A 30-day after procedure follow-up will be conducted for all 188 patients.

Eligibility criteria: 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 treatment, target lesion was expanded by Antegrade Dissection Re-entry (ADR) technique.
* Patient who cannot accept anticoagulant or antiplatelet therapy
* Aware of patient allergic to heparin, contrast, aspirin and clopidogrel, anesthetics
* Patients who have not completed clinical trials of other drugs or devices
* Patients with poor compliance and unable to complete the study, which is identified by investigator.

Primary outcomes:
measure: Achievement of Optimal PTA in Percent
timeFrame: 1 day
Secondary outcomes:
measure: Device Success Rate in Percent
timeFrame: 1 day
measure: Numerical Acute Lumen Gain in mm
timeFrame: 1 day
measure: Technical Success Rate in percent
timeFrame: 0-7 days
measure: Freedom from clinical-driven TLR rate in percent
timeFrame: 30+/-7 Days post procedure
measure: Rutherford Grading Reduction in percent
timeFrame: 30+/-7 Days post procedure
measure: Freedom from Amputation above ankle rate in percent
timeFrame: 30+/-7 Days post procedure
measure: Numerical Ankle Brachial Index
timeFrame: 0-7days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Ha'erbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Chengdu
country: China
facility: Hospital of Chengdu Traditional Chinese Medicine University
state: Sichuan
city: Chengdu
country: China
facility: The Third People's Hospital of Chengdu
state: Sichuan
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Xuanwu Hospital of Capital Medical University
city: Shanghai
country: China
facility: The First Affiliated Hospital of Naval Medical University
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Weiguo Fu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: