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Vascular Closure Device

Mynx Control Venous Closure for Venous Vascular Closure (ReliaSeal Trial)

N/A
Waitlist Available
Research Sponsored by Cordis Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post procedure
Awards & highlights

Summary

This trial is testing a new device to see if it is better than manual compression to seal femoral access sites after endovascular procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint: Time to Ambulation
Primary Effectiveness Endpoint: Time to Hemostasis
Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days
Secondary outcome measures
Device Success
Procedural Success
Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mynx Control Venous ClosureExperimental Treatment1 Intervention
204 (2:1 randomized - 136 VCD:68 manual compression)
Group II: Manual CompressionActive Control1 Intervention
204 (2:1 randomized - 136 VCD:68 manual compression)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MYNX CONTROL™ Venous Vascular Closure Device 6F-12F
2022
N/A
~360

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Who is running the clinical trial?

Cordis CorporationLead Sponsor
91 Previous Clinical Trials
123,306 Total Patients Enrolled
NAMSAOTHER
49 Previous Clinical Trials
19,358 Total Patients Enrolled
~117 spots leftby Sep 2025
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