Heart DiseasesNCT00804024
ClearWay™ RX Registry Trial
An observational study of Heart Diseases and Vascular Diseases, run by Atrium Medical Corporation at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Diseases, Vascular Diseases
- What is being tested?
- ClearWay™ RX Local Therapeutic Infusion Catheter
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 102 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2008to Oct 2010
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The ClearWay Rx Registry enrolled subjects who required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.
Who may be able to join
- Subject required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.
Who cannot join
- Subject not meeting the above inclusion criterion
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Presbyterian Hospital Mid-Carolina Cardiology
Charlotte, North Carolina, 28204
St.Mary's Duluth Clinic Health System
Duluth, Minnesota, 55805
Escondido Cardiology Associates
Escondido, California, 92025
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
Clarian Health Partners Methodist Research Institute
Indianapolis, Indiana, 46202
Good Samaritan Hospital
Lebanon, Pennsylvania, 17042
The Georgia Heart Center
Macon, Georgia, 31202
Western Baptist Hospital
Paducah, Kentucky, 42003
Virginia Cardiovascular Specialists
Richmond, Virginia, 23225
Great Lakes Heart & Vascular Institute
Saint Joseph, Michigan, 49085
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Forsyth Medical Center-Cardiovascular Research
Winston-Salem, North Carolina, 27103
Winter Haven Florida
Winter Haven, Florida, 33881
About this study
Official title: Multi-center, Registry Trial of ClearWay™ RX Local Therapeutic Infusion Catheter for All Indications
The primary goal of this registry is to collect data regarding the use of the ClearWay RX Local Therapeutic Infusion Catheter for all indications.
Read the 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.
- Conditions
- Heart Diseases, Vascular Diseases
- Being tested
- ClearWay™ RX Local Therapeutic Infusion Catheter
- Keywords
- Heart Diseases. Vascular Diseases.
- Medical subject headings
- Heart Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearWay™ RX Local Therapeutic Infusion CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ClearWay™ RX | Not described Receives: Device: ClearWay™ RX Local Therapeutic Infusion Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
use, easy of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Atrium Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, M.D., Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804024
- Sponsor's protocol ID
- 20080711
- Status last verified
- Apr 2013
- First submitted
- 5 Dec 2008
- Last updated
- 19 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Registry Trial of ClearWay™ RX Local Therapeutic Infusion Catheter for All Indications
- ClinicalTrials.gov ID
- NCT00804024
- Acronym / sponsor ID
- 20080711
- Conditions
- Heart Diseases, Vascular Diseases
- Keywords
- Heart Diseases. Vascular Diseases.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Atrium Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ClearWay™ RX | – | Device: ClearWay™ RX Local Therapeutic Infusion Catheter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The ClearWay Rx Registry enrolled subjects who required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.
Key inclusion criteria (1 listed)
- Subject required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.
Key exclusion criteria (1 listed)
- Subject not meeting the above inclusion criterion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClearWay™ RX Local Therapeutic Infusion CatheterThe 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. | Device | ClearWay™ RX |
Primary outcome
use, easy of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Waksman, M.D. principal investigator
Medstar Health Research Institute
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Vascular Diseases, run by Atrium Medical Corporation at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
use, easy of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation. (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2013.