Back to resultsAcoArt Ⅰ / SFA China
Primary Purpose
Peripheral Artery Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
drug eluting balloon catheter (trade name: Orchid)
common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease focused on measuring drug eluting balloon catheter
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
Sites / Locations
- Xiyuan Hospital CACMS
- Chinese PLA General Hospital
- The First Affiliated Hospital of Chongqing Medical University
- The First Affiliated Hospital of Fujian Medical University
- The First Affiliated Hospital, Sun Yat-sen University
- The second Hospital Of Hebei University
- The First Affiliated Hospital, Dalian Medical University
- The People's Hospital of Liaoning Province
- Zhongshan Hospital Fudan University
- Renji Hospital ShangHai Jiaotong University School Of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
drug eluting balloon catheter
common balloon catheter(uncoated drug)
Arm Description
use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery
Outcomes
Primary Outcome Measures
Late Lumen Loss
measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
Secondary Outcome Measures
Minimal lumen diameter (MLD)
measure minimal lumen diameter (MLD) of target lesion
Restenosis rate of target vessel
stenosis over 50% is defined as restenosis
target lesion revascularization
target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
change in Rutherford stage
based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment
Stage clinical symptom
0 asymptomatic
mild claudication
moderate claudication
severe claudication
ischemic rest pain
minor tissue loss
ulceration or gangrene
change in ankle brachial index(ABI)
change in ankle brachial index(ABI) compared to pretreatment
major amputation
major amputation at the index limb(major amputation is defined as an amputation above the foot)
Death
death of any cause
Full Information
NCT ID
NCT01850056
First Posted
April 27, 2013
Last Updated
July 11, 2018
Sponsor
Acotec Scientific Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01850056
Brief Title
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
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acotec Scientific Co., Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
drug eluting balloon catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
drug eluting balloon catheter
Arm Type
Experimental
Arm Description
use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
Arm Title
common balloon catheter(uncoated drug)
Arm Type
Active Comparator
Arm Description
use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery
Intervention Type
Device
Intervention Name(s)
drug eluting balloon catheter (trade name: Orchid)
Other Intervention Name(s)
drug eluting dilation catheter
Intervention Type
Device
Intervention Name(s)
common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)
Other Intervention Name(s)
common PTA catheter
Primary Outcome Measure Information:
Title
Late Lumen Loss
Description
measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Minimal lumen diameter (MLD)
Description
measure minimal lumen diameter (MLD) of target lesion
Time Frame
6 months
Title
Restenosis rate of target vessel
Description
stenosis over 50% is defined as restenosis
Time Frame
6 months, 12 months, 18 months, 24months
Title
target lesion revascularization
Description
target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
Time Frame
6 months, 12 months, 18 months, 24 months
Title
change in Rutherford stage
Description
based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment
Stage clinical symptom
0 asymptomatic
mild claudication
moderate claudication
severe claudication
ischemic rest pain
minor tissue loss
ulceration or gangrene
Time Frame
6 months, 12 months, 18 months, 24 months
Title
change in ankle brachial index(ABI)
Description
change in ankle brachial index(ABI) compared to pretreatment
Time Frame
6 months
Title
major amputation
Description
major amputation at the index limb(major amputation is defined as an amputation above the foot)
Time Frame
6 months, 12 months, 18 months, 24 months
Title
Death
Description
death of any cause
Time Frame
12 months, 18 months, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Xiyuan Hospital CACMS
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The second Hospital Of Hebei University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
The First Affiliated Hospital, Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
The People's Hospital of Liaoning Province
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Renji Hospital ShangHai Jiaotong University School Of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34385840
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.
Results Reference
derived
PubMed Identifier
32903168
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.
Results Reference
derived
Learn more about this trial
AcoArt Ⅰ / SFA China
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