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Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device

NCT03923387 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2022-06-22

No results posted yet for this study

Summary

To evaluate the safety and effectiveness of MynxGrip, in hemostasis of common femoral artery puncture site, compared with manual compression hemostasis in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.

Conditions

  • Endovascular

Interventions

DEVICE

MynxGrip

Vascular Closure

OTHER

Manual compression

Manual compression is a commonly used method to achieve hemostasis of femoral artery

Sponsors & Collaborators

  • Cardinal Health

    collaborator INDUSTRY

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Prof. Miao Zhongrong, MD · Beijing Tian Tan Hospital, Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2020-09-01
Completion
2020-09-01
FDA Device
Yes

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 NCT03923387 on ClinicalTrials.gov