Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures

NCT07554976 | Recruiting

• 1 other identifier: SPD02
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Percutaneous Intervention Via Common Femoral Vein

Outcome Measures

Primary Outcomes (1)

• hemostasis success rate

  within 10 minutes post-suturing

Study Arms (2)

SPIDER

EXPERIMENTAL

Device: SPIDER

Perclose ProGlide

ACTIVE COMPARATOR

Device: Perclose ProGlide

Interventions

SPIDER DEVICE

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).

SPIDER

Perclose ProGlide DEVICE

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.

Perclose ProGlide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Hengruihongyuan Medical Technology Co. LTD: lead

Study Sites (1)

Zhongshan Hospital, Fudan University (Lead Site)

Shanghai, China

RECRUITING

Related Publications (6)

• 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

• 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 BACKGROUND

• 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 Registry. J Am Heart Assoc. 2020 Nov 3;9(21):e018042. doi: 10.1161/JAHA.120.018042. Epub 2020 Oct 24.

  PMID: 33103545 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

Fu Weiguo Fu

CONTACT

13801760929; fu.weiguo@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: November 5, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-12

Locations

CN (1)