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The Safety and Efficacy of the Suture-Mediated Closure System

NCT05841836 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2023-05-03

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease
  • Arterial Puncture

Interventions

DEVICE

the Suture-Mediated Closure System

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

DEVICE

Perclose ProGlide Suture-Mediated Closure System

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

Sponsors & Collaborators

  • Zhejiang Zylox Medical Device Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yu Zhao, Master · First Affiliated Hospital of Chongqing Medical University

  • Hongfei Sang, M.D. · Second Affiliated Hospital of Soochow University

  • Jianming Sun, M.D. · The Second Affiliated Hospital of Chongqing Medical University

  • Changsheng Shi, Master · The Third Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2023-05-30
Completion
2023-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841836 on ClinicalTrials.gov