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A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases

Primary Purpose

Peripheral Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug eluting Balloon
Sponsored by
Zhejiang Zylox Medical Device Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18-85 years；
  • ≥70% diameter stenosis or occlusion in the target below-the-knee lesion；
  • Rutherford Category 3-6；
  • Subjects are willing to sign informed consent；

Exclusion Criteria:

  • Planned major limb amputation within 30 days after the procedure;
  • In-stent stenosis in the target lesion;
  • Severely calcified target lesions；
  • Creatinine>2.5mg/dL;
  • History of allergies to anesthetics, contrast agents；
  • Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint；
  • Other circumstances judged by researchers that are not suitable for enrollment.

Sites / Locations

  • The second hospital of Anhui Medical university
  • Zhongshan Hospital Xiamen University
  • Hebei General Hospital
  • The First Hospital of Hebei Medical University
  • HeNan Province People's Hospital
  • The First Affiliated Hospital Of Zhengzhou University
  • The central hospital of Wuhan
  • Nanjing Drum Tower Hospital, the affiliated hospital of Nanjing University medical school
  • The First Affiliated Hospital Of Dalian Medical University
  • General Hospital of Northern Theater Command
  • The affiliated Hospital of QingDao University
  • Shanxi Bethune Hospital
  • The affiliated hospital of southwest medical university
  • Tianjin Medical University General Hospital
  • Affiliated HangZhou First People's Hospital, Zhejiang University School of medicine
  • Huamei hospital, University of Chinese academy of sciences
  • China-Japan Friendship Hospital
  • Peking University First Hospital
  • Changhai HospitalRecruiting
  • Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group

101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group

Arm Description

Patients in this group use Drug eluting Balloon (Zylox-tonbridge), this is the product to be test in this clinical trail. The drug we coated is paclitaxel.

Patients in this group use Drug eluting Balloon(Acotec), this is a product that has got approved by NMPA in 2016.

Outcomes

Primary Outcome Measures

Rate of primary patency of the target lesion
Primary patency is defined as no target lesion occlusion, no clinical symptom driven target lesion revascularization and major limb amputation.

Secondary Outcome Measures

Success rate of the device
Success rate of the device is defined as a situation that the balloon catheter reached the lesion site, dilated successfully without rupture, and was successfully withdrawn.
Success rate of the technique
On the basis of device success,technique success rate is defined as restored blood flow in the lesion after the treatment, and the residual stenosis ≤30%.
Success rate of the operation
On the basis of technique success, operation success is defined as no adverse event happening.

Full Information

First Posted
June 6, 2022
Last Updated
June 10, 2022
Sponsor
Zhejiang Zylox Medical Device Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05415995
Brief Title
A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases
Official Title
A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Zylox Medical Device Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.
Detailed Description
This trail is conducted in several centers all around China. 202 subjects with below the knee arterial stenosis or occlusion will be recruited and randomized, this trail compares the efficacy and safety of Drug-coated Balloon (Zylox-Tonbridge) with a similar balloon catheter producted by Acotec. The subjects will be followed up when discharged /in 30 days/ 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group
Arm Type
Experimental
Arm Description
Patients in this group use Drug eluting Balloon (Zylox-tonbridge), this is the product to be test in this clinical trail. The drug we coated is paclitaxel.
Arm Title
101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group
Arm Type
Active Comparator
Arm Description
Patients in this group use Drug eluting Balloon(Acotec), this is a product that has got approved by NMPA in 2016.
Intervention Type
Device
Intervention Name(s)
Drug eluting Balloon
Intervention Description
Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall.
Primary Outcome Measure Information:
Title
Rate of primary patency of the target lesion
Description
Primary patency is defined as no target lesion occlusion, no clinical symptom driven target lesion revascularization and major limb amputation.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Success rate of the device
Description
Success rate of the device is defined as a situation that the balloon catheter reached the lesion site, dilated successfully without rupture, and was successfully withdrawn.
Time Frame
Intraoperation
Title
Success rate of the technique
Description
On the basis of device success,technique success rate is defined as restored blood flow in the lesion after the treatment, and the residual stenosis ≤30%.
Time Frame
Immediately after the intervention
Title
Success rate of the operation
Description
On the basis of technique success, operation success is defined as no adverse event happening.
Time Frame
Within 7 days
Other Pre-specified Outcome Measures:
Title
Change of Ankle-Branchial Index(ABI)
Description
ABI is a simple measurement identifies unrecognized Peripheral Arterial Disease.
Time Frame
180 days
Title
The rate of target lesion revascularization(TLR)
Description
TLR is defined as revascularization of the target lesion with stenosis ≥70%.
Time Frame
30 days/ 180 days

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 18-85 years； ≥70% diameter stenosis or occlusion in the target below-the-knee lesion； Rutherford Category 3-6； Subjects are willing to sign informed consent； Exclusion Criteria: Planned major limb amputation within 30 days after the procedure; In-stent stenosis in the target lesion; Severely calcified target lesions； Creatinine>2.5mg/dL; History of allergies to anesthetics, contrast agents； Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint； Other circumstances judged by researchers that are not suitable for enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Liang
Phone
13819565660
Email
jie.liang@zyloxmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junmin Bao
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The second hospital of Anhui Medical university
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengyun Wan
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojin Huang
Facility Name
Hebei General Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoming Shi
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Zhang
Facility Name
HeNan Province People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuiting Zhai
Facility Name
The First Affiliated Hospital Of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Li
Facility Name
The central hospital of Wuhan
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao He
Facility Name
Nanjing Drum Tower Hospital, the affiliated hospital of Nanjing University medical school
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoqiang Li
Facility Name
The First Affiliated Hospital Of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Wang
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Jiang
Facility Name
The affiliated Hospital of QingDao University
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingjin Guo
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendong Cao
Facility Name
The affiliated hospital of southwest medical university
City
Luzhou
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Liu
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangchen Dai
Facility Name
Affiliated HangZhou First People's Hospital, Zhejiang University School of medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xupin Xie
Facility Name
Huamei hospital, University of Chinese academy of sciences
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dehai Lang
Facility Name
China-Japan Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DongZhi Ye
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YingHua Zou
Facility Name
Changhai Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junmin Bao
Facility Name
Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minyi Yin

12. IPD Sharing Statement

Learn more about this trial

A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases

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