Peripheral Artery DiseasePINTONCT05562076
Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection
A study testing the spot stent(ZENFLEX ® Pinto) system and the bare stent( Everflex) system in people with Peripheral Artery Disease, run by Zhejiang Zylox Medical Device Co., Ltd. at 12 sites in China.
Trial summary
This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- the spot stent(ZENFLEX ® Pinto) system and the bare stent( Everflex) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 12 sitesChina
- Study dates
- Nov 2022to Feb 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years,male or female
- Lower extremity atherosclerotic occlusive disease
- After PTA, angiography showed less than 30% residual stenosis of the target lesion (based on visual estimation), and there is one or more dissection(Type A-F)
- Subjects are able to understand the purpose of the study, demonstrate full compliance with the procedure and follow-up and sign informed consent
Who cannot join
- The target lesion has been stented or previously treated with bypass surgery
- Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours
- Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned
- More than 30% residual stenosis of the inflow artery (based on visual estimation) after treatment, or there is no outflow artery in the target limb
- The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion
- Planned amputation on the target limb
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- Severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and Nitinol
- Uncontrollable infections
- Women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial
- Participating in clinical trials of any other drug or medical device and not yet out of the study
- Other circumstances not suitable for inclusion as judged by the investigator
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Xuanwu Hospital, Capital Medical University
Beijing
Lianrui Guo
The First Affiliated Hospital of Bengbu Medical College
Bengbu
Chaowen Yu
Changzhou First People's Hospital
Changzhou
Yufeng Zhu
Changzhou Second People's Hospital
Changzhou
Yunfeng Zhu
The First Affiliated Hospital of Harbin Medical University
Ha’erbin
Bing Liu
Anhui Provincial Hospital
Hefei
The Second Affiliated Hospital of Nanchang University
Nanchang
Weimin Zhou
Nanjing Drum Tower Hospital
Nanjing
Xiaoqiang Li
Affiliated Hospital of Qingdao University
Qingdao
Mingjin Guo
Shanghai Ninth People's Hospital
Shanghai
Xinwu Lu
Tianjin Medical University General Hospital
Tianjin
Xiangchen Dai
North Jiangsu People's Hospital
Yangzhou
Zhaolei Chen
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trail Using Spot Stenting to Treat Lower Extremity Post-angioplasty Dissection
This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.
- Conditions
- Peripheral Artery Disease
- Being tested
- the spot stent(ZENFLEX ® Pinto) system, the bare stent( Everflex) system
- 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.
the spot stent(ZENFLEX ® Pinto) systemDevice
the spot stent(ZENFLEX ® Pinto) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
the bare stent( Everflex) systemDevice
the bare stent( Everflex) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
| Study group | Role | What they receive |
|---|---|---|
| ZENFLEX ® Pinto | Experimental | subjects using the spot stent(ZENFLEX ® Pinto) system Receives: Device: the spot stent(ZENFLEX ® Pinto) system |
| Everflex | Active comparator | subjects using the bare stent(Everflex) system Receives: Device: the bare stent( Everflex) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary patency rate at 12 months after operation
Measured: 12 months
Secondary outcomes (10)
success rate of the device
Measured: Intraoperation
success rate of the technique
Measured: post operation
rate of CD-TLR
Measured: 6 months,12 months
ABI
Measured: post operation, 6 months,12 months
Rutherford classification
Measured: post operation, 6 months,12 months
the incidence of major adverse events
Measured: 30 days, 6 months,12 months
the rate of target limb major amputation
Measured: 30 days, 6 months,12 months
the incidence of adverse events
Measured: Intraoperation, post operation, 30 days, 6 months,12 months
the incidence of SAE
Measured: Intraoperation, post operation, 30 days, 6 months,12 months
the rate of device defect
Measured: Intraoperation, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study startNov 2022 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2025 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoqiang Li, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562076
- Sponsor's protocol ID
- 72202207
- Acronym
- PINTO
- Status last verified
- Sep 2022
- First submitted
- 15 Aug 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trail Using Spot Stenting to Treat Lower Extremity Post-angioplasty Dissection
- ClinicalTrials.gov ID
- NCT05562076
- Acronym / sponsor ID
- PINTO / 72202207
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2022 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 30 Sep 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 spot stenting to treat lower extremity post-angioplasty dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZENFLEX ® Pinto | Experimental | Device: the spot stent(ZENFLEX ® Pinto) systemsubjects using the spot stent(ZENFLEX ® Pinto) system |
| Everflex | Active comparator | Device: the bare stent( Everflex) systemsubjects using the bare stent(Everflex) system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 80 years,male or female
- Lower extremity atherosclerotic occlusive disease
- After PTA, angiography showed less than 30% residual stenosis of the target lesion (based on visual estimation), and there is one or more dissection(Type A-F)
- Subjects are able to understand the purpose of the study, demonstrate full compliance with the procedure and follow-up and sign informed consent
Key exclusion criteria (11 listed)
- The target lesion has been stented or previously treated with bypass surgery
- Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours
- Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned
- More than 30% residual stenosis of the inflow artery (based on visual estimation) after treatment, or there is no outflow artery in the target limb
- The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion
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 |
|---|---|---|
| the spot stent(ZENFLEX ® Pinto) systemthe spot stent(ZENFLEX ® Pinto) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA） | Device | ZENFLEX ® Pinto |
| the bare stent( Everflex) systemthe bare stent( Everflex) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA） | Device | Everflex |
Primary outcome
primary patency rate at 12 months after operation
Time frame: 12 months
10 secondary outcomes
success rate of the device
Time frame: Intraoperation
success rate of the technique
Time frame: post operation
rate of CD-TLR
Time frame: 6 months,12 months
ABI
Time frame: post operation, 6 months,12 months
Rutherford classification
Time frame: post operation, 6 months,12 months
the incidence of major adverse events
Time frame: 30 days, 6 months,12 months
the rate of target limb major amputation
Time frame: 30 days, 6 months,12 months
the incidence of adverse events
Time frame: Intraoperation, post operation, 30 days, 6 months,12 months
the incidence of SAE
Time frame: Intraoperation, post operation, 30 days, 6 months,12 months
the rate of device defect
Time frame: Intraoperation, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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.
Xiaoqiang Li principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the spot stent(ZENFLEX ® Pinto) system and the bare stent( Everflex) system in people with Peripheral Artery Disease, run by Zhejiang Zylox Medical Device Co., Ltd. at 12 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 11 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 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
primary patency rate at 12 months after operation (time frame: 12 months). 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 30 Sep 2022.