AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China
Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of the Infrapopliteal Artery
1 other identifier
interventional
120
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2014
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 5, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2020
CompletedJune 18, 2021
June 1, 2021
4.5 years
May 5, 2014
June 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Patency [Time Frame: 6 months]
Freedom from target vessel occlusion and clinically driven target lesion reintervention
6 months
Secondary Outcomes (10)
device success rate
during the operation(after using the DEB catheter)
technical success rates
during the operation(after using the DEB catheter)
operation success rate
during the operation(after using the DEB catheter)
if occured clinically driven TLR( target lesion revascularization)
6 months, 12 months,18 months, 24 months
target lesion late lumen loss 6 months
6 months
- +5 more secondary outcomes
Study Arms (2)
DEB catheter
EXPERIMENTALuse DEB catheter(trade name: Lotus/Tulip) to treat the stenosis or occlusion in below popliteal artery of experimental arm
common PTA balloon catheter
ACTIVE COMPARATORuse common PTA balloon catheter(trade name:Amphirion Deep) to treat stenosis or occlusion in below popliteal artery of control group
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
People's Liberation Army General Hospital
Beijing, 100853, China
Peking Union Medical College Hospital
Beijing, China
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, China
Xuanwu Hospital, Capital Medical University
Beijing, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Tianjin Medical University General Hospital
Tianjin, China
Related Publications (1)
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.
PMID: 33118432DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Guo
Chinese PLA General Hospital
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
May 5, 2014
First Posted
May 14, 2014
Study Start
May 1, 2014
Primary Completion
November 1, 2018
Study Completion
December 17, 2020
Last Updated
June 18, 2021
Record last verified: 2021-06