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Access Safety and Efficacy Post Endovascular Intervention

NCT01773148 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2015-02-24

No results posted yet for this study

Summary

The goal of this study is to assess the safety and effectiveness of the AXERA Access System in subjects undergoing Common Femoral Artery (CFA) access for Percutaneous Coronary Intervention (PCI) and/or Peripheral Vascular Intervention (PVI) through a 5 French (F) or 6F introducer sheath.

Conditions

  • Cardiovascular Disease.

Interventions

DEVICE

Arstasis Access System (AXERA)

Placement of the AXERA device in the Femoral Artery.

Sponsors & Collaborators

  • Arstasis, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Dorogy, MD · The Medical Center of Central Georgia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-03-31
Completion
2015-06-30

Countries

  • United States

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 NCT01773148 on ClinicalTrials.gov