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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

MEDRAD, Inc.

ClinicalTrials.gov Identifier:

NCT00778336

First received: October 22, 2008

Last updated: July 9, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 22, 2008

Last Updated Date

July 9, 2012

Start Date ^ICMJE

January 2007

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Change From Baseline to Final Angiographic Results [ Time Frame: Index Procedure ( pre-endovascular treatment and post-endovascular treatment) ] [ Designated as safety issue: No ]

From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms,each vessel was assigned a value by the treating physician:

complete occlusion (> 90% occlusion);
substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);
partial occlusion (<50% occlusion AND <3cm in length);
patent (Without visable thrombus or occlusion).

The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic value from the final value.

Original 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 ]

Change History

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

Current Secondary Outcome Measures ^ICMJE

Rethrombosis [ Time Frame: 3 Month Follow Up ] [ Designated as safety issue: No ]
The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).
Description of Treatments by Thrombotic Condition [ Time Frame: Index Procedure ] [ Designated as safety issue: No ]
The # of patients that were exposed to each treatment at least once in the given thrombotic condition.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Peripheral Vascular Diseases
Thrombosis
Venous Thrombosis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Limb Ischemia
Patients presenting with limb ischemia for treatment
Deep Vein Thrombosis
Patients presenting with deep vein thrombosis for treatment
Hemodialysis Access
Patients presenting with thrombosed hemodialysis access for treatment
Other Thrombotic Conditions
Patients presenting with thrombosed conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

452

Completion Date

April 2010

Primary Completion Date

March 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

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00778336

Other Study ID Numbers ^ICMJE

PEARL

Has Data Monitoring Committee

Responsible Party

MEDRAD, Inc.

Study Sponsor ^ICMJE

MEDRAD, Inc.

Collaborators ^ICMJE

Not Provided

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, Inc.

Verification Date

July 2012

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

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