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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Procedure: DEB catheter; Procedure: common PTA balloon catheter

Detailed Description

PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia.

DEBs are designed to promote arterial patency by reducing neointimal proliferation.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • BeiJing, China, 100853
    • People's Liberation Army General Hospital
  • Beijing, China
    • Peking Union Medical College Hospital
  • Beijing, China
    • Xuanwu Hospital, Capital Medical University
  • Beijing, China
    • Xiyuan Hospital, China Academy of Chinese Medical Sciences
  • Dalian, China
    • The First Affiliated Hospital of Dalian Medical University
  • Guangzhou, China
    • The First Affiliated Hospital, Sun Yat-sen University
  • Shanghai, China
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China
    • The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
  • Shenyang, China
    • ShengJing Hospital Of China Medical University
  • Shijiazhuang, China
    • The Second Hospital of Hebei Medical University
  • Tianjin, China
    • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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: DEB catheter; use DEB catheter(trade name: Lotus/Tulip) to treat the stenosis or occlusion in below popliteal artery of experimental arm	Procedure: DEB catheter; DEB catheter (trade name: Litos/Tulip)
Active Comparator: common PTA balloon catheter; use common PTA balloon catheter(trade name:Amphirion Deep) to treat stenosis or occlusion in below popliteal artery of control group	Procedure: common PTA balloon catheter; common PTA balloon catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency [Time Frame: 6 months]	Freedom from target vessel occlusion and clinically driven target lesion reintervention	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
device success rate	DEB catheter can reach the target lesions, expand as expected(not broken), and withdraw successfully.	during the operation(after using the DEB catheter)
technical success rates	The blood supply of the target lesion recovered after treatment, and residual stenosis less than 50%	during the operation(after using the DEB catheter)
operation success rate	both device succeed and technical succeed, and without clinical complication	during the operation(after using the DEB catheter)
if occured clinically driven TLR( target lesion revascularization)	Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as: resting pain occur again, ulcer deterioration, new foot ulcers	6 months, 12 months,18 months, 24 months
target lesion late lumen loss 6 months	measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months	6 months
Ulcer healing rate	Healed or not, if not, improving,stagnant, worsening	6 months, 12 months
Ulcer healing time	Healed or not	6 months, 12 months, 18 months, 24 months
Change from baseline ankle brachial index(ABI) at 6 months	measure ankle brachial index >1.3 Vascular wall calcification is severe 0.9~1.1 Normal range 0.5~0.8 Mild and moderate ischemia of lower limb arteries <0.5 severe ischemia	6 months
change from baseline Rutherford stage at 6 months	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
limb salvage in surviving subjects	No Amputation of target limb	30 days, 6 months, 12 months,18 months, 24 months

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd
• Investigators: Principal Investigator: Wei Guo, Chinese PLA General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

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-03