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AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China

Primary Purpose

Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DEB catheter
common PTA balloon catheter
Sponsored by
Acotec Scientific Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring drug eluting balloon catheter

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DEB catheter

common PTA balloon catheter

Arm Description

use DEB catheter(trade name: Lotus/Tulip) to treat the stenosis or occlusion in below popliteal artery of experimental arm

use common PTA balloon catheter(trade name:Amphirion Deep) to treat stenosis or occlusion in below popliteal artery of control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

device success rate
DEB catheter can reach the target lesions, expand as expected(not broken), and withdraw successfully.
technical success rates
The blood supply of the target lesion recovered after treatment, and residual stenosis less than 50%
operation success rate
both device succeed and technical succeed, and without clinical complication
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
target lesion late lumen loss 6 months
measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
Ulcer healing rate
Healed or not, if not, improving,stagnant, worsening
Ulcer healing time
Healed or not
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
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
limb salvage in surviving subjects
No Amputation of target limb

Full Information

First Posted
May 5, 2014
Last Updated
June 17, 2021
Sponsor
Acotec Scientific Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02137577
Brief Title
AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China
Official Title
Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of the Infrapopliteal Artery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
December 17, 2020 (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 using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.
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.

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
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEB catheter
Arm Type
Experimental
Arm Description
use DEB catheter(trade name: Lotus/Tulip) to treat the stenosis or occlusion in below popliteal artery of experimental arm
Arm Title
common PTA balloon catheter
Arm Type
Active Comparator
Arm Description
use common PTA balloon catheter(trade name:Amphirion Deep) to treat stenosis or occlusion in below popliteal artery of control group
Intervention Type
Procedure
Intervention Name(s)
DEB catheter
Intervention Description
DEB catheter (trade name: Litos/Tulip)
Intervention Type
Procedure
Intervention Name(s)
common PTA balloon catheter
Intervention Description
common PTA balloon catheter
Primary Outcome Measure Information:
Title
Primary Patency [Time Frame: 6 months]
Description
Freedom from target vessel occlusion and clinically driven target lesion reintervention
Time Frame
6 months
Secondary Outcome Measure Information:
Title
device success rate
Description
DEB catheter can reach the target lesions, expand as expected(not broken), and withdraw successfully.
Time Frame
during the operation(after using the DEB catheter)
Title
technical success rates
Description
The blood supply of the target lesion recovered after treatment, and residual stenosis less than 50%
Time Frame
during the operation(after using the DEB catheter)
Title
operation success rate
Description
both device succeed and technical succeed, and without clinical complication
Time Frame
during the operation(after using the DEB catheter)
Title
if occured clinically driven TLR( target lesion revascularization)
Description
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
Time Frame
6 months, 12 months,18 months, 24 months
Title
target lesion late lumen loss 6 months
Description
measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
Time Frame
6 months
Title
Ulcer healing rate
Description
Healed or not, if not, improving,stagnant, worsening
Time Frame
6 months, 12 months
Title
Ulcer healing time
Description
Healed or not
Time Frame
6 months, 12 months, 18 months, 24 months
Title
Change from baseline ankle brachial index(ABI) at 6 months
Description
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
Time Frame
6 months
Title
change from baseline Rutherford stage at 6 months
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
limb salvage in surviving subjects
Description
No Amputation of target limb
Time Frame
30 days, 6 months, 12 months,18 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Guo
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
People's Liberation Army General Hospital
City
BeiJing
ZIP/Postal Code
100853
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Xiyuan Hospital, China Academy of Chinese Medical Sciences
City
Beijing
Country
China
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Facility Name
The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33118432
Citation
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.
Results Reference
derived

Learn more about this trial

AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China

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