ClearWay™ RX Registry Trial

NCT ID: NCT00804024

Last Updated: 2013-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-10-31

Brief Summary

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The primary goal of this registry is to collect data regarding the use of the ClearWay RX Local Therapeutic Infusion Catheter for all indications.

Detailed Description

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The registry will collect de-identified data regarding the indication for use, ease of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.

Conditions

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Heart Diseases Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ClearWay™ RX

ClearWay™ RX Local Therapeutic Infusion Catheter

Intervention Type DEVICE

The ClearWay™ RX Local Therapeutic Infusion Catheter is a micro-porous PTFE balloon catheter designed for the localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature.

Interventions

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ClearWay™ RX Local Therapeutic Infusion Catheter

The ClearWay™ RX Local Therapeutic Infusion Catheter is a micro-porous PTFE balloon catheter designed for the localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.

Exclusion Criteria

* Subject not meeting the above inclusion criterion
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atrium Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ron Waksman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

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Escondido Cardiology Associates

Escondido, California, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Winter Haven Florida

Winter Haven, Florida, United States

Site Status

The Georgia Heart Center

Macon, Georgia, United States

Site Status

Clarian Health Partners Methodist Research Institute

Indianapolis, Indiana, United States

Site Status

Western Baptist Hospital

Paducah, Kentucky, United States

Site Status

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Site Status

Great Lakes Heart & Vascular Institute

Saint Joseph, Michigan, United States

Site Status

St.Mary's Duluth Clinic Health System

Duluth, Minnesota, United States

Site Status

Presbyterian Hospital Mid-Carolina Cardiology

Charlotte, North Carolina, United States

Site Status

Forsyth Medical Center-Cardiovascular Research

Winston-Salem, North Carolina, United States

Site Status

Good Samaritan Hospital

Lebanon, Pennsylvania, United States

Site Status

Virginia Cardiovascular Specialists

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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20080711

Identifier Type: -

Identifier Source: org_study_id

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