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)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: drug eluting balloon catheter (trade name: Orchid); Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital
    • Beijing, Beijing, China, 100091
      • Xiyuan Hospital CACMS
  • Chongqing
    • Chongqing, Chongqing, China
      • The First Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Fuzhou, Fujian, China
      • The First Affiliated Hospital Of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital, Sun Yat-sen University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The second Hospital Of Hebei University
  • Liaoning
    • Dalian, Liaoning, China
      • The First Affiliated Hospital, Dalian Medical University
    • Shenyang, Liaoning, China
      • The People's Hospital of Liaoning Province
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Fudan University
    • Shanghai, Shanghai, China
      • Renji Hospital Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: drug eluting balloon catheter; use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery	Device: drug eluting balloon catheter (trade name: Orchid); Other Names: drug eluting dilation catheter
Active Comparator: common balloon catheter(uncoated drug); use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery	Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral); Other Names: common PTA catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late Lumen Loss	measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal lumen diameter (MLD)	measure minimal lumen diameter (MLD) of target lesion	6 months
Restenosis rate of target vessel	stenosis over 50% is defined as restenosis	6 months, 12 months, 18 months, 24months
target lesion revascularization	target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion	6 months, 12 months, 18 months, 24 months
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	6 months, 12 months, 18 months, 24 months
change in ankle brachial index(ABI)	change in ankle brachial index(ABI) compared to pretreatment	6 months
major amputation	major amputation at the index limb(major amputation is defined as an amputation above the foot)	6 months, 12 months, 18 months, 24 months
Death	death of any cause	12 months, 18 months, 24 months

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 27, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (Estimate): May 9, 2013

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: drug eluting balloon catheter
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: acotec-02