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

A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion

This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Drug eluting Balloon

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.

• Study Type: Interventional
• Enrollment (Anticipated): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Not yet recruiting
    • China-Japan Friendship Hospital
    • Principal Investigator: DongZhi Ye
  • Beijing, China
    • Not yet recruiting
    • Peking University First Hospital
  • Shanghai, China
    • Recruiting
    • Changhai Hospital
    • Principal Investigator: Junmin Bao
  • Shanghai, China
    • Not yet recruiting
    • Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
    • Principal Investigator: Minyi Yin
  • Anhui
    • Hefei, Anhui, China
      • Not yet recruiting
      • The Second Hospital of Anhui Medical University
      • Principal Investigator: Shengyun Wan
  • Fujian
    • Xiamen, Fujian, China
      • Not yet recruiting
      • Zhongshan Hospital Xiamen University
      • Principal Investigator: Xiaojin Huang
  • Hebei
    • Shijiazhuang, Hebei, China
      • Not yet recruiting
      • Hebei General Hospital
      • Principal Investigator: Xiaoming Shi
    • Shijiazhuang, Hebei, China
      • Not yet recruiting
      • The First Hospital of Hebei Medical University
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan province people's hospital
  • Hubei
    • Wuhan, Hubei, China
      • Not yet recruiting
      • The Central Hospital of Wuhan
      • Principal Investigator: Tao He
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
  • Liaoning
    • Dalian, Liaoning, China
      • Not yet recruiting
      • The First Affiliated Hospital of Dalian Medical University
    • Shenyang, Liaoning, China
      • Not yet recruiting
      • General Hospital of Northern Theater Command
      • Principal Investigator: Hong Jiang
  • Shandong
    • Qingdao, Shandong, China
      • Not yet recruiting
      • The Affiliated Hospital Of Qingdao University
      • Principal Investigator: Mingjin Guo
  • Shanxi
    • Taiyuan, Shanxi, China
      • Not yet recruiting
      • Shanxi Bethune Hospital
      • Principal Investigator: Wendong Cao
  • Sichuan
    • Luzhou, Sichuan, China
      • Not yet recruiting
      • The Affiliated Hospital of Southwest Medical University
  • Tianjin
    • Tianjin, Tianjin, China
      • Not yet recruiting
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
      • Principal Investigator: Xupin Xie
    • Ningbo, Zhejiang, China
      • Not yet recruiting
      • Huamei Hospital, University of Chinese Academy of Sciences
      • Principal Investigator: Dehai Lang

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group; 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.	Device: Drug eluting Balloon; 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.
ACTIVE_COMPARATOR: 101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group; Patients in this group use Drug eluting Balloon(Acotec), this is a product that has got approved by NMPA in 2016.	Device: Drug eluting Balloon; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperation
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%.	Immediately after the intervention
Success rate of the operation	On the basis of technique success, operation success is defined as no adverse event happening.	Within 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Ankle-Branchial Index(ABI)	ABI is a simple measurement identifies unrecognized Peripheral Arterial Disease.	180 days
The rate of target lesion revascularization(TLR)	TLR is defined as revascularization of the target lesion with stenosis ≥70%.	30 days/ 180 days

Collaborators and Investigators

• Sponsor: Zhejiang Zylox Medical Device Co., Ltd.
• Investigators: Principal Investigator: Junmin Bao, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (ACTUAL): June 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: V1.1/2021-12-25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No