Femoral Micropuncture or Routine Introducer Study

NCT ID: NCT01103141

Last Updated: 2017-05-11

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-04-30

Brief Summary

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FEMORIS is a marketing study approved by institutional review boards to compare the rates of complications found when using either the Micropuncture® needle introducer or a standard gauge-18 needle to access the groin blood vessels.

Detailed Description

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Conditions

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Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Micropuncture

Group Type ACTIVE_COMPARATOR

Micropuncture needle set

Intervention Type DEVICE

Groin access for vascular intervention

Standard

Group Type ACTIVE_COMPARATOR

Standard gauge-18 needle set

Intervention Type DEVICE

Groin access for vascular intervention

Interventions

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Micropuncture needle set

Groin access for vascular intervention

Intervention Type DEVICE

Standard gauge-18 needle set

Groin access for vascular intervention

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Undergoing left heart catheterization with anticipated or possible percutaneous coronary intervention

Exclusion Criteria

* Left heart cardiac catheterization purely for diagnostic purposes where percutaneous coronary intervention is not anticipated
* Catheterization utilizes primary vascular access site other than the groin
* Catheterization is intended for right heart procedure alone or combined with left and right heart procedures
* Age less than 18 years
* Patient has planned intervention or access utilizing the same groin within 14 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, San Francisco, Fresno, School of Medicine

Fresno, California, United States

Site Status

St. Vincent Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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09-012

Identifier Type: -

Identifier Source: org_study_id

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