ClearWay™ RX Registry Trial
Multi-center, Registry Trial of ClearWay™ RX Local Therapeutic Infusion Catheter for All Indications
1 other identifier
observational
102
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2008
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 5, 2008
CompletedFirst Posted
Study publicly available on registry
December 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedApril 19, 2013
April 1, 2013
2.2 years
December 5, 2008
April 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
use, easy of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.
immediate
Study Arms (1)
ClearWay™ RX
Interventions
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.
Eligibility Criteria
The ClearWay Rx Registry enrolled subjects who required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.
You may qualify if:
- Subject required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Escondido Cardiology Associates
Escondido, California, 92025, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Winter Haven Florida
Winter Haven, Florida, 33881, United States
The Georgia Heart Center
Macon, Georgia, 31202, United States
Clarian Health Partners Methodist Research Institute
Indianapolis, Indiana, 46202, United States
Western Baptist Hospital
Paducah, Kentucky, 42003, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Great Lakes Heart & Vascular Institute
Saint Joseph, Michigan, 49085, United States
St.Mary's Duluth Clinic Health System
Duluth, Minnesota, 55805, United States
Presbyterian Hospital Mid-Carolina Cardiology
Charlotte, North Carolina, 28204, United States
Forsyth Medical Center-Cardiovascular Research
Winston-Salem, North Carolina, 27103, United States
Good Samaritan Hospital
Lebanon, Pennsylvania, 17042, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, 23225, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Waksman, M.D.
Medstar Health Research Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2008
First Posted
December 8, 2008
Study Start
August 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
April 19, 2013
Record last verified: 2013-04