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MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study

NCT02908880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2019-09-25

Study results available
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Summary

Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.

Conditions

  • Femoral Arteriotomy Closure

Interventions

DEVICE

MANTA vascular closure device

The appropriate size of MANTA closure device will be selected and used for the closure of femoral arterial access sites following the use of 10-14F devices or sheaths or the use of 15-18F devices or sheaths.

Sponsors & Collaborators

  • Essential Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • David Wood, MD · St. Paul's Hospital

  • Zvonimir Krajcer, MD · St. Luke's Episcopal

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-10-31
Completion
2017-12-31

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 NCT02908880 on ClinicalTrials.gov