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MANTA Ultrasound Closure Study

NCT05142566 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-07-27

Study results available
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Summary

Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.

Conditions

  • Femoral Arteriotomy Closure

Interventions

DEVICE

MANTA Vascular Closure Device

Evaluate the safety of ultrasound guided deployment of MANTA VCD.

Sponsors & Collaborators

  • Teleflex

    collaborator INDUSTRY

  • Essential Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • David Wood · Vancouver General Hospital

  • Vijay Iyer · University at Buffalo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2023-01-11
Completion
2023-01-11
FDA Device
Yes

Countries

  • United States
  • Canada

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 NCT05142566 on ClinicalTrials.gov