Peripheral Arterial Disease (PAD)UltraFuture INCT05498740
Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia
A study testing Drug eluting Balloon in people with Peripheral Arterial Disease (PAD), run by Zhejiang Zylox Medical Device Co., Ltd. at 24 sites in China.
Trial summary
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease (PAD)
- 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
- 200 participants
- Where
- 24 sitesChina
- Study dates
- 4 May 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and ≤85 years old
- Rutherford clinical category classification：2-5
- Significant stenosis (≥50%) or occlusions of lesion(s) located in the superficial femoral artery an /or the popliteal artery
- At least one patent native outflow artery to the ankle free from significant lesion as confirmed by angiography
- Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.
Who cannot join
- Aneurysms near target lesions or popliteal aneurysms.
- The guide wire cannot pass smoothly through the target lesion.
- Known allergy to contrast agents, heparin or paclitaxel.
- Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints or may enroll in other studies after enrollment in this clinical trial.
- Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
- Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites, 24 recruiting
- Recruiting
Xuanwu hospital
Beijing
Yongquan Gu
- Recruiting
Affiliated Hospital of Chengde Medical College
Chengde
Hong Zhang
- Recruiting
The Third People's Hospital of Chengdu
Chengdu
Chi Cui
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian
Ming Qi
- Recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian
Lei Song
- Recruiting
Guangzhou Huaqiao hospital
Guangzhou
Yan Zhang
- Recruiting
Hospital of Traditional Chinese Medicine affiliated to Guangzhou Medical University
Guangzhou
Meng Du
- Recruiting
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou
Chenyu Yang
- Recruiting
The First Affiliated Hospital of Harbin Medical University
Ha’erbin
Bing Liu
- Recruiting
Hangzhou First People's Hospital
Hangzhou
Xin Fang
- Recruiting
First Hospital of Lanzhou University
Lanzhou
Xiaojun Shu
- Recruiting
Ningbo huamei hospital
Ningbo
Dehai Lang
- Recruiting
Qingdao Municipal Hospital
Qingdao
Dalin Li
- Recruiting
Ruian People's Hospital
Rui’an
Changsheng Shi
- Recruiting
Shanghai Ninth People'S Hospital
Shanghai
Minyi Yin
- Recruiting
Zhongshan Hospital
Shanghai
Weiguo Fu
- Recruiting
Northern Theatre General Hospital
Shenyang
Hong Jiang
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Xiangchen Dai
- Recruiting
Tianjin People's Hospital
Tianjin
Li Su
- Recruiting
Weifang People's Hospital
Weifang
Jiefeng Zhang
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Jingyong Huang
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou
Xiangtao Zheng
- Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
Xi'an
Hongyan Tian
- Recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Xinjiang
Sheng Guan
About this study
Official title: Post-marketing Study in Femoral Popliteal Artery of Drug Coated Ballon Used for Treatment of Lower Limb Ischemia
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
- Conditions
- Peripheral Arterial Disease (PAD)
- 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 |
|---|---|---|
| drug eluting balloon catheter | Experimental | use drug eluting balloon catheter to treat the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery Receives: Device: Drug eluting Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of device success
Measured: intraoperative
rate of procedural success
Measured: intraoperative
rate of technical success
Measured: intraoperative
rate of primary patency of target lesion
Measured: 12 months
rate of primary patency of target lesion
Measured: 24 months
rate of Clinically-driven TLR
Measured: 12 months
rate of Clinically-driven TLR
Measured: 24 months
rate of TLR
Measured: 1 month
rate of TLR
Measured: 12 months
rate of TLR
Measured: 24 months
rate of Clinically-driven TVR
Measured: 12 months
rate of Clinically-driven TVR
Measured: 24 months
rate of TVR
Measured: 1 month
rate of TVR
Measured: 12 months
rate of TVR
Measured: 24 months
change in Rutherford clinical category (target limb)
Measured: 12 months
change in Rutherford clinical category (target limb)
Measured: 24 months
change in ankle brachial index(ABI)
Measured: 12 months
change in ankle brachial index(ABI)
Measured: 24 months
rate of SAE
Measured: 12 months
rate of SAE
Measured: 24 months
rate of All-cause mortality
Measured: 1 month
rate of All-cause mortality
Measured: 12 months
rate of All-cause mortality
Measured: 24 months
rate of Major amputation
Measured: 1 month
rate of Major amputation
Measured: 12 months
rate of Major amputation
Measured: 24 months
rate of target lesion thrombosis
Measured: 12 months
rate of target lesion thrombosis
Measured: 24 months
Rate of adverse events
Measured: intraoperative
Rate of adverse events
Measured: 1 month
Rate of adverse events
Measured: 12 months
Rate of adverse events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start4 May 2022
- Primary completionDec 2022 (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 Arterial Disease (PAD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiguo Fu, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498740
- Sponsor's protocol ID
- 04202106
- Acronym
- UltraFuture I
- Status last verified
- Aug 2022
- First submitted
- 22 Jul 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Study in Femoral Popliteal Artery of Drug Coated Ballon Used for Treatment of Lower Limb Ischemia
- ClinicalTrials.gov ID
- NCT05498740
- Acronym / sponsor ID
- UltraFuture I / 04202106
- Conditions
- Peripheral Arterial Disease (PAD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 May 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Aug 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.
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drug eluting balloon catheter | Experimental | Device: Drug eluting Balloonuse drug eluting balloon catheter to treat the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old and ≤85 years old
- Rutherford clinical category classification：2-5
- Significant stenosis (≥50%) or occlusions of lesion(s) located in the superficial femoral artery an /or the popliteal artery
- At least one patent native outflow artery to the ankle free from significant lesion as confirmed by angiography
- Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.
Key exclusion criteria (6 listed)
- Aneurysms near target lesions or popliteal aneurysms.
- The guide wire cannot pass smoothly through the target lesion.
- Known allergy to contrast agents, heparin or paclitaxel.
- Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints or may enroll in other studies after enrollment in this clinical trial.
- Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
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 | drug eluting balloon catheter |
Primary outcome
rate of device success
Time frame: intraoperative
rate of procedural success
Time frame: intraoperative
rate of technical success
Time frame: intraoperative
rate of primary patency of target lesion
Time frame: 12 months
rate of primary patency of target lesion
Time frame: 24 months
rate of Clinically-driven TLR
Time frame: 12 months
rate of Clinically-driven TLR
Time frame: 24 months
rate of TLR
Time frame: 1 month
rate of TLR
Time frame: 12 months
rate of TLR
Time frame: 24 months
rate of Clinically-driven TVR
Time frame: 12 months
rate of Clinically-driven TVR
Time frame: 24 months
rate of TVR
Time frame: 1 month
rate of TVR
Time frame: 12 months
rate of TVR
Time frame: 24 months
change in Rutherford clinical category (target limb)
Time frame: 12 months
change in Rutherford clinical category (target limb)
Time frame: 24 months
change in ankle brachial index(ABI)
Time frame: 12 months
change in ankle brachial index(ABI)
Time frame: 24 months
rate of SAE
Time frame: 12 months
rate of SAE
Time frame: 24 months
rate of All-cause mortality
Time frame: 1 month
rate of All-cause mortality
Time frame: 12 months
rate of All-cause mortality
Time frame: 24 months
rate of Major amputation
Time frame: 1 month
rate of Major amputation
Time frame: 12 months
rate of Major amputation
Time frame: 24 months
rate of target lesion thrombosis
Time frame: 12 months
rate of target lesion thrombosis
Time frame: 24 months
Rate of adverse events
Time frame: intraoperative
Rate of adverse events
Time frame: 1 month
Rate of adverse events
Time frame: 12 months
Rate of adverse events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Weiguo Fu principal investigator
Shanghai Zhongshan Hospital
24 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 Arterial Disease (PAD), run by Zhejiang Zylox Medical Device Co., Ltd. at 24 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 5 inclusion and 6 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 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 device success (time frame: intraoperative). The study lists 33 primary outcomes in all. 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 12 Aug 2022.