Percutaneous Intervention Via Common Femoral VeinNCT07554976
Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures
A study testing SPIDER and Perclose ProGlide in people with Percutaneous Intervention Via Common Femoral Vein, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 1 site 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 Percutaneous Common Femoral Vein Procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Intervention Via Common Femoral Vein
- What is being tested?
- SPIDER and Perclose ProGlide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- Patients eligible for interventional catheter-based examination or treatment via common femoral artery puncture using sheaths sized 5F to 21F
- Signed by the patient personally or by their legal representative on the Informed Consent Form
Who cannot join
- Known pregnancy or lactation period;
- Diameter of the common femoral artery on the puncture side < 5 mm;
- Concurrent participation in another clinical research study;
- Known allergy to any device component, and/or contraindications to contrast agents or anticoagulants;
- Vascular injury at the access site;
- Infection of the inguinal puncture site;
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- Morbid obesity (BMI ≥ 40 kg/m²);
- Lower extremity vascular ultrasound for assessment of common femoral artery stenosis ≥50%;
- Presence of femoral artery aneurysm, arteriovenous fistula, or pseudoaneurysm in the common femoral artery;
- Previous use of clip-based vascular closure devices at the ipsilateral arterial access site;
- Hematoma at the ipsilateral arterial access site;
- Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University (Lead Site)
Shanghai
符伟国 符, 13801760929, fu.weiguo@zs-hospital.sh.cn
About this study
Official title: Prospective, Multicenter, Randomized Controlled Study to Evaluate the Efficacy and Safety of a Suture-Mediated Closure System Following Percutaneous Common Femoral Vein 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 Percutaneous Common Femoral Vein 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
- SPIDER, Perclose ProGlide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIDERDevice
The intervention utilizes the Vascular Suture System (Model: SPD-100) developed by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd., composed of a vascular suturing device and a suture trimmer. It is intended for closing percutaneous vascular puncture sites in patients undergoing interventional catheter diagnosis or treatment. For femoral artery punctures, it is compatible with 5F-21F sheaths (for sheaths >8F, at least 2 devices and pre-embedded suture technology are required); for femoral vein punctures, it suits 5F-24F sheaths (for sheaths >8F, at least 1 device and pre-embedded suture technology are needed).
Perclose ProGlideDevice
The intervention employs the Perclose ProGlide Vascular Closure System (Model: 12673) manufactured by Abbott, a clinically validated device for closing percutaneous vascular puncture sites. It is indicated for patients undergoing interventional catheter diagnosis or treatment via femoral artery puncture with 5F-21F sheaths, serving as the control in this prospective, multi-center, randomized controlled trial. The device operates by percutaneously delivering sutures through a guidewire: during or after surgery, it accesses the puncture site, deploys sutures to approximate the vascular wall, and secures the suture knot to achieve hemostasis, with the suture permanently implanted in the body.
| Study group | Role | What they receive |
|---|---|---|
| SPIDER | Experimental | Not described Receives: Device: SPIDER |
| Perclose ProGlide | Active comparator | Not described Receives: Device: Perclose ProGlide |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemostasis success rate
Measured: within 10 minutes post-suturing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start5 Nov 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Intervention Via Common Femoral VeinStudies 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
- 136 participants (estimated)
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
- NCT07554976
- Sponsor's protocol ID
- SPD02
- Status last verified
- Dec 2025
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
脑血管介入术后穿刺血管局部血管缝合器压迫时间的临床观察
血管缝合及吻合基本技术与缝线材料选择专家共识(2008)
经股动脉介入诊疗术后应用血管缝合器安全性的系统评价及Meta分析
Robertson L, Andras A, Colgan F, Jackson R. Vascular closure devices for femoral arterial puncture site haemostasis. Cochrane Database Syst Rev. 2016 Mar 7;3(3):CD009541. doi: 10.1002/14651858.CD009541.pub2.
PubMed 26948236Berti S, Bedogni F, Giordano A, Petronio AS, Iadanza A, Bartorelli AL, Reimers B, Spaccarotella C, Trani C, Attisano T, Marella Cenname A, Sardella G, Bonmassari R, Medda M, Tomai F, Tarantini G, Navarese EP; Italian Society of Interventional Cardiology-GISEdagger. Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry. J Am Heart Assoc. 2020 Nov 3;9(21):e018042. doi: 10.1161/JAHA.120.018042. Epub 2020 Oct 24.
PubMed 33103545Vinayakumar D, Kayakkal S, Rajasekharan S, Thottian JJ, Sankaran P, Bastian C. 24h and 30 day outcome of Perclose Proglide suture mediated vascular closure device: An Indian experience. Indian Heart J. 2017 Jan-Feb;69(1):37-42. doi: 10.1016/j.ihj.2016.06.008. Epub 2016 Jun 28.
PubMed 28228304
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled Study to Evaluate the Efficacy and Safety of a Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures
- ClinicalTrials.gov ID
- NCT07554976
- Acronym / sponsor ID
- SPD02
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTDIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 28 Apr 2026 (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 Percutaneous Common Femoral Vein 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 |
|---|---|---|
| SPIDER | Experimental | Device: SPIDER |
| Perclose ProGlide | Active comparator | Device: Perclose ProGlide |
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 to 80 years
- Patients eligible for interventional catheter-based examination or treatment via common femoral artery puncture using sheaths sized 5F to 21F
- Signed by the patient personally or by their legal representative on the Informed Consent Form
Key exclusion criteria (12 listed)
- Known pregnancy or lactation period;
- Diameter of the common femoral artery on the puncture side < 5 mm;
- Concurrent participation in another clinical research study;
- Known allergy to any device component, and/or contraindications to contrast agents or anticoagulants;
- Vascular injury at the access site;
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 |
|---|---|---|
| SPIDERThe intervention utilizes the Vascular Suture System (Model: SPD-100) developed by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd., composed of a vascular suturing device and a suture trimmer. It is intended for closing percutaneous vascular puncture sites in patients undergoing interventional catheter diagnosis or treatment. For femoral artery punctures, it is compatible with 5F-21F sheaths (for sheaths >8F, at least 2 devices and pre-embedded suture technology are required); for femoral vein punctures, it suits 5F-24F sheaths (for sheaths >8F, at least 1 device and pre-embedded suture technology are needed). | Device | SPIDER |
| Perclose ProGlideThe intervention employs the Perclose ProGlide Vascular Closure System (Model: 12673) manufactured by Abbott, a clinically validated device for closing percutaneous vascular puncture sites. It is indicated for patients undergoing interventional catheter diagnosis or treatment via femoral artery puncture with 5F-21F sheaths, serving as the control in this prospective, multi-center, randomized controlled trial. The device operates by percutaneously delivering sutures through a guidewire: during or after surgery, it accesses the puncture site, deploys sutures to approximate the vascular wall, and secures the suture knot to achieve hemostasis, with the suture permanently implanted in the body. | Device | Perclose ProGlide |
Primary outcome
hemostasis success rate
Time frame: within 10 minutes post-suturing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background脑血管介入术后穿刺血管局部血管缝合器压迫时间的临床观察
- Background血管缝合及吻合基本技术与缝线材料选择专家共识(2008)
- Background经股动脉介入诊疗术后应用血管缝合器安全性的系统评价及Meta分析
- Background: PubMed 26948236Robertson L, Andras A, Colgan F, Jackson R. Vascular closure devices for femoral arterial puncture site haemostasis. Cochrane Database Syst Rev. 2016 Mar 7;3(3):CD009541. doi: 10.1002/14651858.CD009541.pub2.
- Background: PubMed 33103545Berti S, Bedogni F, Giordano A, Petronio AS, Iadanza A, Bartorelli AL, Reimers B, Spaccarotella C, Trani C, Attisano T, Marella Cenname A, Sardella G, Bonmassari R, Medda M, Tomai F, Tarantini G, Navarese EP; Italian Society of Interventional Cardiology-GISEdagger. Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry. J Am Heart Assoc. 2020 Nov 3;9(21):e018042. doi: 10.1161/JAHA.120.018042. Epub 2020 Oct 24.
- Background: PubMed 28228304Vinayakumar D, Kayakkal S, Rajasekharan S, Thottian JJ, Sankaran P, Bastian C. 24h and 30 day outcome of Perclose Proglide suture mediated vascular closure device: An Indian experience. Indian Heart J. 2017 Jan-Feb;69(1):37-42. doi: 10.1016/j.ihj.2016.06.008. Epub 2016 Jun 28.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPIDER and Perclose ProGlide in people with Percutaneous Intervention Via Common Femoral Vein, run by Suzhou Hengruihongyuan Medical Technology 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 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fu Weiguo Fu (13801760929, fu.weiguo@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemostasis success rate (time frame: within 10 minutes post-suturing). 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 NCT07554976, which also lists 6 linked publications.
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 28 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.