AcoArt Ⅰ / SFA China
Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)
1 other identifier
interventional
200
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 27, 2013
CompletedFirst Posted
Study publicly available on registry
May 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJuly 12, 2018
December 1, 2015
3.3 years
April 27, 2013
July 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Late Lumen Loss
measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
6 months
Secondary Outcomes (7)
Minimal lumen diameter (MLD)
6 months
Restenosis rate of target vessel
6 months, 12 months, 18 months, 24months
target lesion revascularization
6 months, 12 months, 18 months, 24 months
change in Rutherford stage
6 months, 12 months, 18 months, 24 months
change in ankle brachial index(ABI)
6 months
- +2 more secondary outcomes
Study Arms (2)
drug eluting balloon catheter
EXPERIMENTALuse drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
common balloon catheter(uncoated drug)
ACTIVE COMPARATORuse common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Xiyuan Hospital CACMS
Beijing, Beijing Municipality, 100091, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The second Hospital Of Hebei University
Shijiazhuang, Hebei, 050000, China
The First Affiliated Hospital, Dalian Medical University
Dalian, Liaoning, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Renji Hospital ShangHai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, China
Related Publications (2)
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.
PMID: 34385840DERIVEDSun 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.
PMID: 32903168DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2013
First Posted
May 9, 2013
Study Start
April 1, 2013
Primary Completion
August 1, 2016
Study Completion
September 1, 2016
Last Updated
July 12, 2018
Record last verified: 2015-12