Peripheral Arterial DiseaseNCT03844724
Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
A study testing ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter and Peripheral Balloon Dilatation Catheter in people with Peripheral Arterial Disease and Iliac Artery Stenosis, run by Zhejiang Zylox Medical Device Co., Ltd..
Trial summary
Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease, Iliac Artery Stenosis, Femoral Artery Stenosis
- What is being tested?
- ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter and Peripheral Balloon Dilatation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2015to 22 Oct 2018
- 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
- Aged from 18 to 85 years old, male or female
- Subject's target lesions were stenosis and/or occlusion
- Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent
Who cannot join
- Pregnant woman or who's pregnancy test is positive
- Lactation period woman or woman/man with fertility plan
About this study
Official title: Safety and Efficacy of ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Iliac, Femoral and Popliteal Artery Stenosis or Occlusion
Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion
Read the detailed description
The purpose of this study was to evaluate the safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter (paclitaxel 3±1 μg/mm2 balloon surface area) in the treatment of iliac artery, femoral artery and popliteal stenosis or occlusive lesions compared with conventional PTA balloon dilatation catheter.
- Conditions
- Peripheral Arterial Disease, Iliac Artery Stenosis, Femoral Artery Stenosis, Popliteal Artery Stenosis, Iliac Artery Occlusion, Femoral Artery Occlusion
- Being tested
- ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter, Peripheral Balloon Dilatation Catheter
- Keywords
- Peripheral Arterial Disease, Drug-eluting PTA Balloon Dilatation Catheter, Late Lumen Loss（6 months）
- 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.
ZENFlow™ Drug-eluting PTA Balloon Dilatation CatheterDevice
Digital subtraction angiography（DSA）
Peripheral Balloon Dilatation CatheterDevice
Digital subtraction angiography（DSA）
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | subjects using the drug-eluting PTA balloon dilatation catheter Receives: Device: ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter |
| Group B | Active comparator | subjects using the peripheral balloon dilatation catheter Receives: Device: Peripheral Balloon Dilatation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Lumen Loss at 6 months after operation
Late Lumen Loss
Measured: 6 months
Secondary outcomes (2)
The incidence of major adverse events
Related to death of clinical trials
Measured: 12 months
Adverse Event
Adverse medical events, whether or not related to the medical device
Measured: Preoperative、Intraoperative、up to 1 month、3 months、6 months、9 months、12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start10 Apr 2015
- Primary completion5 Mar 2018
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changwei Liu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844724
- Sponsor's protocol ID
- ZYLOX2014001
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ni L, Ye W, Zhang L, Jin X, Shu C, Jiang JS, Yang M, Wu DM, Li M, Yu GF, Yang J, Huang JH, Wang XB, Li XQ, Jiang WL, Wu ZQ, Liu CW. A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions. Front Cardiovasc Med. 2022 Mar 15;9:821672. doi: 10.3389/fcvm.2022.821672. eCollection 2022.
PubMed 35391838
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Iliac, Femoral and Popliteal Artery Stenosis or Occlusion
- ClinicalTrials.gov ID
- NCT03844724
- Acronym / sponsor ID
- ZYLOX2014001
- Conditions
- Peripheral Arterial Disease, Iliac Artery Stenosis, Femoral Artery Stenosis, Popliteal Artery Stenosis, Iliac Artery Occlusion, Femoral Artery Occlusion
- Keywords
- Peripheral Arterial Disease, Drug-eluting PTA Balloon Dilatation Catheter, Late Lumen Loss（6 months）
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2015 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 18 Feb 2019 (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.
Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion
Detailed description
The purpose of this study was to evaluate the safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter (paclitaxel 3±1 μg/mm2 balloon surface area) in the treatment of iliac artery, femoral artery and popliteal stenosis or occlusive lesions compared with conventional PTA balloon dilatation catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: ZENFlow™ Drug-eluting PTA Balloon Dilatation Cathetersubjects using the drug-eluting PTA balloon dilatation catheter |
| Group B | Active comparator | Device: Peripheral Balloon Dilatation Cathetersubjects using the peripheral balloon dilatation catheter |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged from 18 to 85 years old, male or female
- Subject's target lesions were stenosis and/or occlusion
- Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent
Key exclusion criteria (2 listed)
- Pregnant woman or who's pregnancy test is positive
- Lactation period woman or woman/man with fertility plan
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 |
|---|---|---|
| ZENFlow™ Drug-eluting PTA Balloon Dilatation CatheterDigital subtraction angiography（DSA） | Device | Group A |
| Peripheral Balloon Dilatation CatheterDigital subtraction angiography（DSA） | Device | Group B |
Primary outcome
Late Lumen Loss at 6 months after operation
Time frame: 6 months
Late Lumen Loss
2 secondary outcomes
The incidence of major adverse events
Time frame: 12 months
Adverse Event
Time frame: Preoperative、Intraoperative、up to 1 month、3 months、6 months、9 months、12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Derived from this study: PubMed 35391838Ni L, Ye W, Zhang L, Jin X, Shu C, Jiang JS, Yang M, Wu DM, Li M, Yu GF, Yang J, Huang JH, Wang XB, Li XQ, Jiang WL, Wu ZQ, Liu CW. A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions. Front Cardiovasc Med. 2022 Mar 15;9:821672. doi: 10.3389/fcvm.2022.821672. eCollection 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.
Changwei Liu principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter and Peripheral Balloon Dilatation Catheter in people with Peripheral Arterial Disease and Iliac Artery Stenosis, run by Zhejiang Zylox Medical Device Co., Ltd..
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late Lumen Loss at 6 months after operation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03844724, which also lists 1 linked publication.
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 18 Feb 2019.