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Recruiting NCT07554976

Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures

No phase Interventional Percutaneous Intervention Via Common Femoral Vein

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SPIDER, Perclose ProGlide.
Who it may be relevant to
Registry conditions: Percutaneous Intervention Via Common Femoral Vein. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Device SPIDER
    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
  • Device Perclose ProGlide
    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

Primary outcome measures

  • hemostasis success rate [Time frame: within 10 minutes post-suturing]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Hospital, Fudan University (Lead Site) — Shanghai

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. PMID 26948236
  • Berti 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 Regi PMID 33103545
  • Vinayakumar 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. PMID 28228304

Identifiers

NCT: NCT07554976 · SPD02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗