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

NCT ID: NCT00778336

Last Updated: 2014-10-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

452 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Peripheral Vascular Diseases Thrombosis Venous Thrombosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Limb Ischemia

Patients presenting with limb ischemia for treatment

No interventions assigned to this group

Deep Vein Thrombosis

Patients presenting with deep vein thrombosis for treatment

No interventions assigned to this group

Hemodialysis Access

Patients presenting with thrombosed hemodialysis access for treatment

No interventions assigned to this group

Other Thrombotic Conditions

Patients presenting with thrombosed conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lawrence R. Blitz, MD

Role: PRINCIPAL_INVESTIGATOR

Chilton Memorial Hospital, Pompton Plains, NJ

Robert Lookstein, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai School of Medicine, NYC, NY

Eugene Simoni, MD

Role: PRINCIPAL_INVESTIGATOR

Samaritan Vascular Institute, Dayton, OH

Other Identifiers

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PEARL

Identifier Type: -

Identifier Source: org_study_id

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