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NCT00804024 Clinical Trial

ClearWay™ RX Registry Trial

Heart Diseases Clinical Trial

Official title:
Multi-center, Registry Trial of ClearWay™ RX Local Therapeutic Infusion Catheter for All Indications

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00804024
Other study ID # 20080711
Secondary ID
Status Completed
Phase N/A
First received December 5, 2008
Last updated April 18, 2013
Start date August 2008
Est. completion date October 2010

Study information
Verified date April 2013
Source Atrium Medical Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Subject not meeting the above inclusion criterion

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• 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.

Locations
Country Name City State
United States Presbyterian Hospital Mid-Carolina Cardiology Charlotte North Carolina
United States St.Mary's Duluth Clinic Health System Duluth Minnesota
United States Escondido Cardiology Associates Escondido California
United States Genesys Regional Medical Center Grand Blanc Michigan
United States Clarian Health Partners Methodist Research Institute Indianapolis Indiana
United States Good Samaritan Hospital Lebanon Pennsylvania
United States The Georgia Heart Center Macon Georgia
United States Western Baptist Hospital Paducah Kentucky
United States Virginia Cardiovascular Specialists Richmond Virginia
United States Great Lakes Heart & Vascular Institute St.Joseph Michigan
United States Washington Hospital Center Washington District of Columbia
United States Forsyth Medical Center-Cardiovascular Research Winston-Salem North Carolina
United States Winter Haven Florida Winter Haven Florida

Sponsors (1)
Lead Sponsor Collaborator
Atrium Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary use, easy of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation. immediate No
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