A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters - Tabular View

Tracking Information

First Received Date ^ICMJE

October 22, 2008

Last Updated Date

October 24, 2008

Start Date ^ICMJE

January 2007

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluate the performance of the AngioJet midlength catheters [ Time Frame: Upon admission for procedure through 3 month follow up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00778336 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

Official Title ^ICMJE

Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

Brief Summary

This registry collects observational data about how mid-length AngioJet catheters (ie XPEEDIOR and DVX models) are used in routine clinical practice.

Detailed Description

The PEARL Registry collects real world data about mid-length AngioJet catheters to:

Characterize usage patterns, treatment approaches, and targeted vessels
Document treatment strategies, including specific techniques and concomitant therapies
Collect outcome data during initial hospitalization and at a 3-month follow-up phone call or visit
Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis, and treatments provided
Identify treatment strategies that may optimize procedural and clinical outcomes, to facilitate development of treatment guidelines
Offer sites a valuable resource for tracking usage and performance of the AngioJet System at their institution

Information collected by the PEARL Registry is intended for educational and clinical research purposes only.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Peripheral Vascular Diseases
Thrombosis
Venous Thrombosis

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

September 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient has been treated with a mid-length AngioJet catheter(defined as 90-120 cm in length)
Patient has provided appropriate authorization per institutional policy and procedure.

Exclusion Criteria:

None

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00778336

Responsible Party

DeeAnn Tinjum / Sr. Clinical Research Manager, Possis Medical

Study ID Numbers ^ICMJE

PEARL

Study Sponsor ^ICMJE

MEDRAD Interventional/Possis

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Lawrence R. Blitz, MD	Chilton Memorial Hospital, Pompton Plains, NJ
Principal Investigator:	Robert Lookstein, MD	Mount Sinai School of Medicine, NYC, NY
Principal Investigator:	Eugene Simoni, MD	Samaritan Vascular Institute, Dayton, OH

Information Provided By

MEDRAD Interventional/Possis

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP