Percutaneous Intervention Via Femoral ArteryNCT05899478
Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures
A study testing Tyknot® Suture-Mediated Closure System and Perclose® ProGlide Suture-Mediated Closure System in people with Percutaneous Intervention Via Femoral Artery, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 5 sites in China.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of the suture-mediated closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. following endovascular peripheral arterial procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Intervention Via Femoral Artery
- What is being tested?
- Tyknot® 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
- 135 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jun 2023to 1 Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80
- Patients who can use 5Fr to 21Fr sheath for common femoral artery puncture for interventional catheterization or therapy
- Informed consent signed by the patient or legal representative
Who cannot join
- Pregnancy or lactation period;
- Diameter of femoral artery site for puncture< 5mm;
- Have participated in another clinical study during the same period;
- Known allergy to any device component, and/or contraindications of contrast agents and anticoagulants;
- Vascular injury at the site of the approach;
- Groin infection;
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- Morbid obesity (BMI≥40kg / ㎡);
- Ultrasonographic assessment of the entire common femoral artery wall showed that the common femoral artery stenosis was ≥ 50%;
- There are femoral aneurysms, arteriovenous fistulas or pseudoaneurysms in the common femoral artery;
- Clamp vessel closures were used at the previous ipsilateral artery approach;
- Hematoma at ipsilateral artery approach;
- Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
The First Affiliated Hospital of USTC
Hefei, Anhui, 230001
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
The Fourth Affiliated Hospital ,Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
About this study
Official title: Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures
The purpose of this study is to evaluate the effectiveness and safety of the suture-mediated closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. following endovascular peripheral arterial procedures.
Read the detailed description
Prospective, multi-center, randomized Comparative study using the Suture-mediated Closure System produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd.as an investigational device and the Perclose® ProGlide Suture-Mediated Closure System as a comparator.
After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two devices. The subjects should follow designated physician's instructions accurately during the clinical trial period. There are about 4 times evaluations Including screening.
- Being tested
- Tyknot® Suture-Mediated Closure System, Perclose® ProGlide Suture-Mediated Closure System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyknot® Suture-Mediated Closure SystemDevice
Arterial closure to ensure hemostasis at femoral artery puncture points
Perclose® ProGlide Suture-Mediated Closure SystemDevice
Arterial closure to ensure hemostasis at femoral artery puncture points
| Study group | Role | What they receive |
|---|---|---|
| Tyknot® Suture-Mediated Closure System | Experimental | Arterial closure device used is Tyknot® Suture-Mediated Closure System Receives: Device: Tyknot® Suture-Mediated Closure System |
| Perclose® ProGlide Suture-Mediated Closure System | Active comparator | Arterial closure device used is 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.
Rate of successful hemostasis
Calculation method: Patients with successful hemostasis / total cases of subjects in the same group x 100%.
Definition of successful hemostasis: Within 10 minutes after completion of the suturing procedure, there is no bleeding or hematoma at the puncture site, and no other intervention or surgical treatment is required.
Measured: 10 minutes
Secondary outcomes (7)
Operation time
The time for suturing with the vascular closure device. Definition of Operation time: The time it takes for the device to enter the artery, tie the knot, and then be successfully withdrawn from the vessel.
Measured: Approximately 15-minutes after device removal
Hemostasis time
The time from the catheter sheath is removed to compression is released and no bleeding occurs at the puncture site
Measured: Approximately 15-minutes after compression
Technical success rate
Calculation method: Patients with technical success/ total cases of subjects in the same group x 100%.
Definition of Technical success: Successful placement of the device,smooth withdrawal, and completion fo the knot.
Measured: Approximately 15-minutes after device removal
Evaluation of Compatibility with guidewires of the device
Scale from 1 point (worst) to 5 points (best)
Measured: Approximately 15-minutes after device removal
Evaluation of Pushing performance of the device
Scale from 1 point (worst) to 5 points (best)
Measured: Approximately 15-minutes after device removal
Evaluation of Withdrawal performance of the device
Scale from 1 point (worst) to 5 points (best)
Measured: Approximately 15-minutes after device removal
Evaluation of Performance of tightening knot of the device
Scale from 1 point (worst) to 5 points (best)
Measured: Approximately 15-minutes after device removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jun 2023
- Primary completion1 Jan 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Intervention Via Femoral ArteryStudies 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899478
- Sponsor's protocol ID
- SPD01
- Status last verified
- Jun 2025
- First submitted
- 5 May 2023
- Last updated
- 25 Jun 2025
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures
- ClinicalTrials.gov ID
- NCT05899478
- Acronym / sponsor ID
- SPD01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 12 Jun 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.
The purpose of this study is to evaluate the effectiveness and safety of the suture-mediated closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. following endovascular peripheral arterial procedures.
Detailed description
Prospective, multi-center, randomized Comparative study using the Suture-mediated Closure System produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd.as an investigational device and the Perclose® ProGlide Suture-Mediated Closure System as a comparator.
After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two devices. The subjects should follow designated physician's instructions accurately during the clinical trial period. There are about 4 times evaluations Including screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tyknot® Suture-Mediated Closure System | Experimental | Device: Tyknot® Suture-Mediated Closure SystemArterial closure device used is Tyknot® Suture-Mediated Closure System |
| Perclose® ProGlide Suture-Mediated Closure System | Active comparator | Device: Perclose® ProGlide Suture-Mediated Closure SystemArterial closure device used is Perclose® ProGlide Suture-Mediated Closure System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-80
- Patients who can use 5Fr to 21Fr sheath for common femoral artery puncture for interventional catheterization or therapy
- Informed consent signed by the patient or legal representative
Key exclusion criteria (12 listed)
- Pregnancy or lactation period;
- Diameter of femoral artery site for puncture< 5mm;
- Have participated in another clinical study during the same period;
- Known allergy to any device component, and/or contraindications of contrast agents and anticoagulants;
- Vascular injury at the site of the approach;
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 |
|---|---|---|
| Tyknot® Suture-Mediated Closure SystemArterial closure to ensure hemostasis at femoral artery puncture points | Device | Tyknot® Suture-Mediated Closure System |
| Perclose® ProGlide Suture-Mediated Closure SystemArterial closure to ensure hemostasis at femoral artery puncture points | Device | Perclose® ProGlide Suture-Mediated Closure System |
Primary outcome
Rate of successful hemostasis
Time frame: 10 minutes
Calculation method: Patients with successful hemostasis / total cases of subjects in the same group x 100%. Definition of successful hemostasis: Within 10 minutes after completion of the suturing procedure, there is no bleeding or hematoma at the puncture site, and no other intervention or surgical treatment is required.
7 secondary outcomes
Operation time
Time frame: Approximately 15-minutes after device removal
Hemostasis time
Time frame: Approximately 15-minutes after compression
Technical success rate
Time frame: Approximately 15-minutes after device removal
Evaluation of Compatibility with guidewires of the device
Time frame: Approximately 15-minutes after device removal
Evaluation of Pushing performance of the device
Time frame: Approximately 15-minutes after device removal
Evaluation of Withdrawal performance of the device
Time frame: Approximately 15-minutes after device removal
Evaluation of Performance of tightening knot of the device
Time frame: Approximately 15-minutes after device removal
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 25 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tyknot® Suture-Mediated Closure System and Perclose® ProGlide Suture-Mediated Closure System in people with Percutaneous Intervention Via Femoral Artery, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 5 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 3 inclusion and 12 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 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
Rate of successful hemostasis (time frame: 10 minutes). 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 25 Jun 2025.