Clinical trial NCT01850056: AcoArt Ⅰ / SFA China
Official title: Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)
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: 2013-05-09
Enrollment: 200
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: The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* Patients with peripheral artery disease (PAD), with Rutherford classification between 2 and 5
* an occlusion or a minimum grade of stenosisPrimary over 70% in the superficial femoral artery an /or the popliteal artery
* Total length of treat lesion(s)is less or equal to 40cm
* signed Patient informed consent form

Exclusion Criteria:

* plasma Cr level greater than 150 umol/L 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
* target lesion can't be cross by the guide wire
* distal outflow through less than one lower leg vessel
* known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
* patients participating in another clinical trials with interfere with this trial in the past 3 months
* pregnancy and lactating woman
* untreatable bleeding diatheses
* other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patients's life expectancy(less than 2 years)
* patients unable or unwilling to participate this trial

Primary outcomes:
measure: Late Lumen Loss
timeFrame: 6 months
Secondary outcomes:
measure: Minimal lumen diameter (MLD)
timeFrame: 6 months
measure: Restenosis rate of target vessel
timeFrame: 6 months, 12 months, 18 months, 24months
measure: target lesion revascularization
timeFrame: 6 months, 12 months, 18 months, 24 months
measure: change in Rutherford stage
timeFrame: 6 months, 12 months, 18 months, 24 months
measure: change in ankle brachial index(ABI)
timeFrame: 6 months
measure: major amputation
timeFrame: 6 months, 12 months, 18 months, 24 months
measure: Death
timeFrame: 12 months, 18 months, 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital CACMS
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shijiazhuang
country: China
facility: The second Hospital Of Hebei University
state: Hebei
city: Dalian
country: China
facility: The First Affiliated Hospital, Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital ShangHai Jiaotong University School Of Medicine
state: Shanghai
Study officials:
References:
citation: Ren H, Liu J, Zhang J, Zhuang B, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W. Five-Year Outcomes of Post-Drug-Coated Balloon Angioplasty Dissection in Complex Femoropopliteal Artery Disease. Int J Gen Med. 2021 Aug 5;14:4197-4207. doi: 10.2147/IJGM.S316916. eCollection 2021.
citation: Sun G, Liu J, Jia S, Zhang J, Zhuang B, Jia X, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W; AcoArt I Trial Investigators. Comparison of drug-coated balloon angioplasty versus uncoated balloon angioplasty in treatment of total occlusions with severe femoropopliteal lesions: An additional analysis from the AcoArt I study. Vascular. 2021 Jun;29(3):340-349. doi: 10.1177/1708538120953663. Epub 2020 Sep 9.