NCT05841836

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

March 31, 2023

Last Update Submit

April 23, 2023

Conditions

Peripheral Arterial DiseaseArterial Puncture

Outcome Measures

Primary Outcomes (1)

  • 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

    30 days after the procedure

Study Arms (2)

the Suture-Mediated Closure System

EXPERIMENTAL

Produced by Zhejiang Zylox Medical Device Co., Ltd.

Device: the Suture-Mediated Closure System

Perclose ProGlide Suture-Mediated Closure System

ACTIVE COMPARATOR

Perclose® ProGlide Suture-Mediated Closure System

Device: Perclose ProGlide Suture-Mediated Closure System

Interventions

the Suture-Mediated Closure SystemDEVICE

To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site

the Suture-Mediated Closure System
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

Perclose ProGlide Suture-Mediated Closure System

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Yu Zhao, Master

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

  • Hongfei Sang, M.D.

    Second Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

  • Jianming Sun, M.D.

    The Second Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

  • Changsheng Shi, Master

    The Third Affiliated Hospital of Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Zhao, Master

CONTACT

13808338199820994765@qq.com

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

March 31, 2023

First Posted

May 3, 2023

Study Start

October 26, 2022

Primary Completion

May 30, 2023

Study Completion

July 30, 2023

Last Updated

May 3, 2023

Record last verified: 2023-04

Locations

CN(1)