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ClearWay™ RX Registry Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00804024
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Atrium Medical Corporation

Brief 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.

Condition or disease Intervention/treatment
Heart Diseases Vascular Diseases Device: ClearWay™ RX Local Therapeutic Infusion Catheter

Detailed 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Multi-center, Registry Trial of ClearWay™ RX Local Therapeutic Infusion Catheter for All Indications
Study Start Date : August 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ClearWay™ RX 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.




Primary Outcome Measures :
  1. use, easy of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation. [ Time Frame: immediate ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The ClearWay Rx Registry enrolled subjects who required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subject not meeting the above inclusion criterion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804024


Locations
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United States, California
Escondido Cardiology Associates
Escondido, California, United States, 92025
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Winter Haven Florida
Winter Haven, Florida, United States, 33881
United States, Georgia
The Georgia Heart Center
Macon, Georgia, United States, 31202
United States, Indiana
Clarian Health Partners Methodist Research Institute
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Western Baptist Hospital
Paducah, Kentucky, United States, 42003
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Great Lakes Heart & Vascular Institute
St.Joseph, Michigan, United States, 49085
United States, Minnesota
St.Mary's Duluth Clinic Health System
Duluth, Minnesota, United States, 55805
United States, North Carolina
Presbyterian Hospital Mid-Carolina Cardiology
Charlotte, North Carolina, United States, 28204
Forsyth Medical Center-Cardiovascular Research
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Good Samaritan Hospital
Lebanon, Pennsylvania, United States, 17042
United States, Virginia
Virginia Cardiovascular Specialists
Richmond, Virginia, United States, 23225
Sponsors and Collaborators
Atrium Medical Corporation
Investigators
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Principal Investigator: Ron Waksman, M.D. Washington Hospital Center
Additional Information:

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Responsible Party: Atrium Medical Corporation
ClinicalTrials.gov Identifier: NCT00804024    
Other Study ID Numbers: 20080711
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013
Keywords provided by Atrium Medical Corporation:
Heart Diseases. Vascular Diseases.
Additional relevant MeSH terms:
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Heart Diseases
Vascular Diseases
Cardiovascular Diseases