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

June 10, 2022 updated by: Zhejiang Zylox Medical Device Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of primary patency of the target lesion
Time Frame: 180 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Success rate of the device
Time Frame: Intraoperation
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
Time Frame: Immediately after the intervention
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
Time Frame: Within 7 days
On the basis of technique success, operation success is defined as no adverse event happening.
Within 7 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of Ankle-Branchial Index(ABI)
Time Frame: 180 days
ABI is a simple measurement identifies unrecognized Peripheral Arterial Disease.
180 days
The rate of target lesion revascularization(TLR)
Time Frame: 30 days/ 180 days
TLR is defined as revascularization of the target lesion with stenosis ≥70%.
30 days/ 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Zylox Medical Device Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Junmin Bao, Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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