Clinical trial NCT02137577: AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China
Official title: Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of the Infrapopliteal Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: drug eluting balloon catheter
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.

Detailed description: PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia.

DEBs are designed to promote arterial patency by reducing neointimal proliferation.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 85 years
* Patients with peripheral artery disease (PAD), with Rutherford classification between 4 and 6
* an occlusion or a minimum grade of stenosis Primary over 70% in the below popliteal artery
* The expected survival time is more than 1 year
* signed Patient informed consent form

Exclusion Criteria:

* Serum creatinine clearance rate less than 30ml/min in patients
* patients with acute thrombosis requiring lysis or thrombectomy
* patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks
* patient requiring intervention in both lower limbs at the same time
* In-stent restenosis in the blow-knee popliteal artery
* target lesion can't be cross by the guide wire
* the stenosis rate of proximal outflow more than 30% with or without intervention
* the length of the stenosis or occlusion in proximal outflow(including the Iliac artery, the superficial femoral artery, the Popliteal artery) more than 150mm before intervention
* stenosis or occlusion of distal outflow for below-the-ankle artery.
* expected major amputations at the index limb before intervention
* known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
* patients participating in another clinical trials with interfere with this trial in the same time
* pregnancy and lactating woman
* untreatable bleeding diatheses

Primary outcomes:
measure: Primary Patency [Time Frame: 6 months]
timeFrame: 6 months
Secondary outcomes:
measure: device success rate
timeFrame: during the operation(after using the DEB catheter)
measure: technical success rates
timeFrame: during the operation(after using the DEB catheter)
measure: operation success rate
timeFrame: during the operation(after using the DEB catheter)
measure: if occured clinically driven TLR( target lesion revascularization)
timeFrame: 6 months, 12 months,18 months, 24 months
measure: target lesion late lumen loss 6 months
timeFrame: 6 months
measure: Ulcer healing rate
timeFrame: 6 months, 12 months
measure: Ulcer healing time
timeFrame: 6 months, 12 months, 18 months, 24 months
measure: Change from baseline ankle brachial index(ABI) at 6 months
timeFrame: 6 months
measure: change from baseline Rutherford stage at 6 months
timeFrame: 6 months, 12 months,18 months, 24 months
measure: limb salvage in surviving subjects
timeFrame: 30 days, 6 months, 12 months,18 months, 24 months
Other outcomes:
Locations:
city: BeiJing
country: China
facility: People's Liberation Army General Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Xiyuan Hospital, China Academy of Chinese Medical Sciences
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Wei Guo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jia X, Zhuang B, Wang F, Gu Y, Zhang J, Lu X, Dai X, Liu Z, Bi W, Liu C, Wang S, Liistro F, Guo W. Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions (AcoArt II-BTK). J Endovasc Ther. 2021 Apr;28(2):215-221. doi: 10.1177/1526602820969681. Epub 2020 Oct 29.