ClearWay™ RX Registry Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Atrium Medical Corporation
ClinicalTrials.gov Identifier:
NCT00804024
First received: December 5, 2008
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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 Intervention
Heart Diseases
Vascular Diseases
Device: ClearWay™ RX Local Therapeutic Infusion Catheter

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Atrium Medical Corporation:

Primary Outcome Measures:
  • use, easy of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation. [ Time Frame: immediate ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: August 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804024

Locations
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
Principal Investigator: Ron Waksman, M.D. Washington Hospital Center
  More Information

No publications provided

Responsible Party: Atrium Medical Corporation
ClinicalTrials.gov Identifier: NCT00804024     History of Changes
Other Study ID Numbers: 20080711
Study First Received: December 5, 2008
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Atrium Medical Corporation:
Heart Diseases. Vascular Diseases.

Additional relevant MeSH terms:
Heart Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014