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A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System

NCT01271946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2013-01-31

Study results available
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Summary

The goal of this study is to observe the clinical safety and effectiveness of the ArstasisOne Access System in patients undergoing diagnostic angiographic procedures through the femoral artery.

Conditions

  • Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer

Interventions

DEVICE

Diagnostic catheterization procedure

Intervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.

Sponsors & Collaborators

  • Arstasis, Inc.

    lead INDUSTRY

Principal Investigators

  • Zoltan Turi, MD · The Cooper Health System

  • John Held, MD · Mercy Hospital Fairfield

  • Frank Kresock, MD · The Cardiovascular Center

  • Tom Hinohara, MD · Sequoia Hospital

  • Dale Wortham, MD · Volunteer Research Group, LLC

  • Greg Sampognaro, MD · P&S

  • Ray Smith, MD · Ark-La-Tex Cardiology/Willis-Knighton Hospital

  • Kalyan Veerina, MD · Cardiovascular Institute of the South-Opelousas

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-05-31
Completion
2011-05-31

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 NCT01271946 on ClinicalTrials.gov