ClearWay™ RX Registry Trial | NCT00804024

Studies
ClearWay™ RX Registry Trial

NCT00804024

Sponsor

Atrium Medical Corporation

Status

Completed

Last Update Posted

Apr 19, 2013Estimated

Enrollment

102Actual

Phase

Not provided

Conditions

Heart Diseases
Vascular Diseases

Interventions

ClearWay™ RX Local Therapeutic Infusion Catheter

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Dec 5, 2008

First Submission Date that Met QC Criteria

Dec 5, 2008

First Posted Date

Dec 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2013

Last Update Posted Date

Apr 19, 2013Estimated

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ClearWay™ RX			Device: ClearWay™ RX Local Therapeutic Infusion Catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ClearWay™ RX Local Therapeutic Infusion Catheter	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
use, easy of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.		immediate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Subject not meeting the above inclusion criterion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The ClearWay Rx Registry enrolled subjects who required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ron Waksman, M.D.	Medstar Health Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Escondido Cardiology Associates		Escondido	California	92025	United States
Washington Hospital Center

Condition Browse Module

MeSH Terms

ID	Term
D006331	Heart Diseases
D014652	Vascular Diseases

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided