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Treatment for Femoral Artery Closure (ACCESS MANTA Trial)

N/A
Recruiting
Research Sponsored by Essential Medical, Inc.
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 within 30 days of tavr procedure
Awards & highlights

Summary

This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures. The study will enroll participants who are undergoing a TAVR procedure. The purpose of this study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the 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
Time to Hemostasis
Secondary outcome measures
Additional interventions: Required at large bore access site to address complications
Ambulation Success
Technical Success
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Who is running the clinical trial?

Essential Medical, Inc.Lead Sponsor
5 Previous Clinical Trials
877 Total Patients Enrolled
Essential Medical LLC a subsidiary of Teleflex, IncorporatedUNKNOWN
~71 spots leftby Jan 2025
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