Peripheral Artery DiseaseNCT05415995
A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases
A study testing Drug eluting Balloon in people with Peripheral Artery Disease, run by Zhejiang Zylox Medical Device Co., Ltd. at 20 sites in China.
Trial summary
This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Drug eluting Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 20 sitesChina
- Study dates
- 1 Mar 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites, 20 recruiting
- Not yet recruiting
China-Japan Friendship Hospital
Beijing
DongZhi Ye
- Not yet recruiting
Peking University First Hospital
Beijing
YingHua Zou
- Not yet recruiting
The First Affiliated Hospital Of Dalian Medical University
Dalian, Liaoning
Feng Wang
- Not yet recruiting
Affiliated HangZhou First People's Hospital, Zhejiang University School of medicine
Hangzhou, Zhejiang
Xupin Xie
- Not yet recruiting
The second hospital of Anhui Medical university
Hefei, Anhui
Shengyun Wan
- Not yet recruiting
The affiliated hospital of southwest medical university
Luzhou, Sichuan
Yong Liu
- Not yet recruiting
Nanjing Drum Tower Hospital, the affiliated hospital of Nanjing University medical school
Nanjing, Jiangsu
Xiaoqiang Li
- Not yet recruiting
Huamei hospital, University of Chinese academy of sciences
Ningbo, Zhejiang
Dehai Lang
- Not yet recruiting
The affiliated Hospital of QingDao University
Qingdao, Shandong
Mingjin Guo
- Recruiting
Changhai Hospital
Shanghai
Junmin Bao
- Not yet recruiting
Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
Shanghai
Minyi Yin
- Not yet recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning
Hong Jiang
- Not yet recruiting
Hebei General Hospital
Shijiazhuang, Hebei
Xiaoming Shi
- Not yet recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Lei Zhang
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Wendong Cao
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Xiangchen Dai
- Not yet recruiting
The central hospital of Wuhan
Wuhan, Hubei
Tao He
- Not yet recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian
Xiaojin Huang
- Not yet recruiting
HeNan Province People's Hospital
Zhengzhou, Henan
Shuiting Zhai
- Not yet recruiting
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan
Zhen Li
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Drug eluting Balloon
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug eluting BalloonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group | Experimental | 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. Receives: Device: Drug eluting Balloon |
| 101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group | Active comparator | Patients in this group use Drug eluting Balloon(Acotec), this is a product that has got approved by NMPA in 2016. Receives: Device: Drug eluting Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Secondary outcomes (3)
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.
Measured: 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%.
Measured: Immediately after the intervention
Success rate of the operation
On the basis of technique success, operation success is defined as no adverse event happening.
Measured: Within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Mar 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junmin Bao, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415995
- Sponsor's protocol ID
- V1.1/2021-12-25
- Status last verified
- Mar 2022
- First submitted
- 6 Jun 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion
- ClinicalTrials.gov ID
- NCT05415995
- Acronym / sponsor ID
- V1.1/2021-12-25
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group | Experimental | Device: Drug eluting BalloonPatients 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. |
| 101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group | Active comparator | Device: Drug eluting BalloonPatients in this group use Drug eluting Balloon(Acotec), this is a product that has got approved by NMPA in 2016. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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；
Key exclusion criteria (7 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug eluting BalloonDrug 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. | Device | 101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group, 101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group |
Primary outcome
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.
3 secondary outcomes
Success rate of the device
Time frame: Intraoperation
Success rate of the technique
Time frame: Immediately after the intervention
Success rate of the operation
Time frame: Within 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junmin Bao principal investigator
Changhai Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug eluting Balloon in people with Peripheral Artery Disease, run by Zhejiang Zylox Medical Device Co., Ltd. at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Liang (13819565660, jie.liang@zyloxmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of primary patency of the target lesion (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.