Peripheral Arterial DiseaseNCT05841836
The Safety and Efficacy of the Suture-Mediated Closure System
A study testing the Suture-Mediated Closure System and Perclose ProGlide Suture-Mediated Closure System in people with Peripheral Arterial Disease and Arterial Puncture, run by Zhejiang Zylox Medical Device Co., Ltd. at 1 site in China.
Trial summary
This was a prospective, multicenter, randomized, controlled, non-inferiority clinical study with the primary objective of validating the safety and efficacy of the Suture-Mediated Closure System for percutaneous closure of the common femoral artery puncture site. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease, Arterial Puncture
- What is being tested?
- the Suture-Mediated Closure System and Perclose ProGlide Suture-Mediated Closure System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2022to 30 Jul 2023
- 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
- Between 18 years old and 85 years old, randomized
- Patients who can be examined or treated with a common femoral artery puncture interventional catheter using a 5F to 22F sheath tube
- Patient(or their guardians) who submitted a written informed consent for the this trial
Who cannot join
- Known to be pregnant or lactating
- The diameter of femoral artery on the puncture side was less than 5mm
- Patients requiring anterograde puncture approach
- Have participated in or plan to participate in another clinical trial in the same period
- Known allergy to any components of the device, and/or contraindications to contrast agents and anticoagulants
- International normalized ratio (INR) >2.0
Show all 20Show fewer
- Traumatic vascular injury at the approach site
- Systemic or local groin infection
- Cerebrovascular accident or myocardial infarction within 3 months
- An arterial catheter needs to be placed at the access site
- Morbidly obese (BMI ≥40 kg/m2)
- The entire common femoral artery wall assessed by ultrasound, calcification located in the anterior wall cut, the extent of more than 50% circumferential or common femoral artery stenosis ≥50
- Femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm in common femoral artery
- Using a clip vessel occluder at the past ipsilateral femoral artery access site
- Use of a puncture point occlusion device at the ipsilateral femoral access site within the past 30 days
- Underwent an intervention via ipsilateral femoral artery puncture within the past 30 days or within the next 30 days
- Ipsilateral femoral vein sheath needed to be used
- Evidence of previous common femoral artery surgery on the same side (e.g., inguinal incision)
- Hematoma at ipsilateral arterial access
- Other circumstances that the investigator deemed inappropriate for participation in the trial.femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm in common femoral artery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
Yu Zhao, Master, 13808338199, 820994765@qq.com
About this study
Official title: A Prospective, Multi-center, Randomized Controlled, Non-inferiority Clinical Trial of the Safety and Efficacy of the Suture-Mediated Closure System for Percutaneous Closure of the Common Femoral Artery Puncture Site
This was a prospective, multicenter, randomized, controlled, non-inferiority clinical study with the primary objective of validating the safety and efficacy of the Suture-Mediated Closure System for percutaneous closure of the common femoral artery puncture site.
Read the detailed description
This study was a prospective, multicenter, randomized, controlled, non-inferiority clinical trial. It is planned to be conducted in multiple clinical trial institutions and enroll 228 subjects. Eligible subjects were randomly divided into the experimental group or the control group at a ratio of 1:1.
- Conditions
- Peripheral Arterial Disease, Arterial Puncture
- Being tested
- the Suture-Mediated Closure System, Perclose ProGlide Suture-Mediated Closure 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 Suture-Mediated Closure SystemDevice
To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site
Perclose ProGlide Suture-Mediated Closure SystemDevice
To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site
| Study group | Role | What they receive |
|---|---|---|
| the Suture-Mediated Closure System | Experimental | Produced by Zhejiang Zylox Medical Device Co., Ltd. Receives: Device: the Suture-Mediated Closure System |
| Perclose ProGlide Suture-Mediated Closure System | Active comparator | Perclose® ProGlide Suture-Mediated Closure System Receives: Device: Perclose ProGlide Suture-Mediated Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major complications at the access site
The number of subjects who experienced major complications as a proportion of the total number of subjects who used the vascular stapler system
Measured: 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start26 Oct 2022
- Primary completion30 May 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Zhao, Master, Principal investigator, First Affiliated Hospital of Chongqing Medical UniversityHongfei Sang, M.D., Principal investigator, Second Affiliated Hospital of Soochow UniversityJianming Sun, M.D., Principal investigator, The Second Affiliated Hospital of Chongqing Medical UniversityChangsheng Shi, Master, Principal investigator, The Third Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841836
- Sponsor's protocol ID
- Zylox20220321
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2023
- Last updated
- 3 May 2023
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled, Non-inferiority Clinical Trial of the Safety and Efficacy of the Suture-Mediated Closure System for Percutaneous Closure of the Common Femoral Artery Puncture Site
- ClinicalTrials.gov ID
- NCT05841836
- Acronym / sponsor ID
- Zylox20220321
- Conditions
- Peripheral Arterial Disease, Arterial Puncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 3 May 2023 (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 was a prospective, multicenter, randomized, controlled, non-inferiority clinical study with the primary objective of validating the safety and efficacy of the Suture-Mediated Closure System for percutaneous closure of the common femoral artery puncture site.
Detailed description
This study was a prospective, multicenter, randomized, controlled, non-inferiority clinical trial. It is planned to be conducted in multiple clinical trial institutions and enroll 228 subjects. Eligible subjects were randomly divided into the experimental group or the control group at a ratio of 1:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Suture-Mediated Closure System | Experimental | Device: the Suture-Mediated Closure SystemProduced by Zhejiang Zylox Medical Device Co., Ltd. |
| Perclose ProGlide Suture-Mediated Closure System | Active comparator | Device: Perclose ProGlide Suture-Mediated Closure SystemPerclose® ProGlide Suture-Mediated Closure System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18 years old and 85 years old, randomized
- Patients who can be examined or treated with a common femoral artery puncture interventional catheter using a 5F to 22F sheath tube
- Patient(or their guardians) who submitted a written informed consent for the this trial
Key exclusion criteria (20 listed)
- Known to be pregnant or lactating
- The diameter of femoral artery on the puncture side was less than 5mm
- Patients requiring anterograde puncture approach
- Have participated in or plan to participate in another clinical trial in the same period
- Known allergy to any components of the device, and/or contraindications to contrast agents and anticoagulants
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 Suture-Mediated Closure SystemTo reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site | Device | the Suture-Mediated Closure System |
| Perclose ProGlide Suture-Mediated Closure SystemTo reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site | Device | Perclose ProGlide Suture-Mediated Closure System |
Primary outcome
Incidence of major complications at the access site
Time frame: 30 days after the procedure
The number of subjects who experienced major complications as a proportion of the total number of subjects who used the vascular stapler system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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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.
Yu Zhao, Master principal investigator
First Affiliated Hospital of Chongqing Medical University
Hongfei Sang, M.D. principal investigator
Second Affiliated Hospital of Soochow University
Jianming Sun, M.D. principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Suture-Mediated Closure System and Perclose ProGlide Suture-Mediated Closure System in people with Peripheral Arterial Disease and Arterial Puncture, run by Zhejiang Zylox Medical Device Co., Ltd. at 1 site 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 3 inclusion and 20 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yu Zhao, Master (13808338199, 820994765@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major complications at the access site (time frame: 30 days after the procedure). 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 3 May 2023.