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

Sponsored by:	Possis Medical
Information provided by:	Possis Medical
ClinicalTrials.gov Identifier:	NCT00778336

Purpose

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

Condition
Peripheral Vascular Diseases Thrombosis Venous Thrombosis

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

Further study details as provided by Possis Medical:

Primary Outcome Measures:

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	January 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Study Population

Patient with peripheral thrombosis treated with a AngioJet mid-length catheter that is indicated for thrombosis removal.

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778336

Sponsors and Collaborators

Possis Medical

Investigators

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

More Information

Responsible Party:	Possis Medical ( DeeAnn Tinjum / Sr. Clinical Research Manager )
Study ID Numbers:	PEARL
Study First Received:	October 22, 2008
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00778336
Health Authority:	United States: Institutional Review Board

Keywords provided by Possis Medical:

Peripheral Thrombosis
DVT
Limb Ischemia

AV Access
AngioJet
Thrombectomy

Study placed in the following topic categories:

Embolism and Thrombosis
Peripheral Vascular Diseases
Embolism
Vascular Diseases

Venous Thrombosis
Ischemia
Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009