Registry of AngioJet Use in the Peripheral Vascular System

NCT ID: NCT01086215

Last Updated: 2014-11-10

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

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-09-30

Brief Summary

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The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system.

Detailed Description

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The PEARL II Registry is a prospective, multi-center, observational registry including 500 patients who meet eligibility from up to 50 sites worldwide. Patient participation will be 12 months including post procedure follow-up contact at 3, 6 and 12 months. The study duration is estimated at 36 months.

A patient's treatment is determined by the treating physician based on the clinical situation and local practices. In contrast to a randomized, controlled trial, there are no pre-defined experimental interventions.

Conditions

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Peripheral Vascular Disease Embolism and 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 a thrombotic condition 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 in the peripheral vascular system with any of the AngioJet System catheters.
* Patient has provided appropriate consent/authorization per the site's institutional policy and procedure.

Exclusion Criteria

* Patient has previously been enrolled in either the PEARL Registry or the PEARL II Registry in the last 12months.
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 Blitz, MD

Role: PRINCIPAL_INVESTIGATOR

Chilton Memorial Hospital

Robert Lookstein, MD

Role: STUDY_DIRECTOR

Icahn School of Medicine at Mount Sinai

Ali Amin, MD

Role: PRINCIPAL_INVESTIGATOR

The Reading Hospital & Medical Center

Locations

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Phoenix Heart, PLLC

Glendale, Arizona, United States

Site Status

John C. Lincoln Deer Valley Hospital

Phoenix, Arizona, United States

Site Status

Good Samaritan Hospital

Los Angeles, California, United States

Site Status

Christiana Care Health System

Newark, Delaware, United States

Site Status

University of Florida- College of Medicine

Jacksonville, Florida, United States

Site Status

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Site Status

Sacred Heart Hospital

Pensacola, Florida, United States

Site Status

Chris Recknor PC

Gainesville, Georgia, United States

Site Status

Indiana University Health Arnett

Lafayette, Indiana, United States

Site Status

Iowa Health

Des Moines, Iowa, United States

Site Status

Cardiovascular Consultants

Bossier City, Louisiana, United States

Site Status

Terrebonne General Medical Center

Houma, Louisiana, United States

Site Status

Regional Medical Center of Acadiana

Lafayette, Louisiana, United States

Site Status

Chilton Memorial Hospital

Pompton Plains, New Jersey, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Grant Medical Center

Columbus, Ohio, United States

Site Status

Good Samaritan Hospital

Dayton, Ohio, United States

Site Status

The University of Toledo Medical Center

Toledo, Ohio, United States

Site Status

St Luke's Hospital & Health Network

Bethlehem, Pennsylvania, United States

Site Status

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Site Status

The Reading Hospital & Medical Center

Reading, Pennsylvania, United States

Site Status

The Miriam Hospital

Providence, Rhode Island, United States

Site Status

University of South Carolina

Charleston, South Carolina, United States

Site Status

North Central Heart Institute

Sioux Falls, South Dakota, United States

Site Status

Holston Valley Medical Center

Kingsport, Tennessee, United States

Site Status

University of Tennessee - Knoxville

Knoxville, Tennessee, United States

Site Status

Winchester Medical Center

Winchester, Virginia, United States

Site Status

Charleston Area Medical Center

Charleston, West Virginia, United States

Site Status

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Winnipeg Regional Health Authority

Winnipeg, Manitoba, Canada

Site Status

Städtisches Klinikum Karlsruhe gGmbH

Karlsruhe, , Germany

Site Status

University of Naples

Naples, , Italy

Site Status

National Institute of CV Diseases

Bratislava, , Slovakia

Site Status

Countries

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United States Canada Germany Italy Slovakia

References

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Garcia MJ, Lookstein R, Malhotra R, Amin A, Blitz LR, Leung DA, Simoni EJ, Soukas PA. Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry. J Vasc Interv Radiol. 2015 Jun;26(6):777-85; quiz 786. doi: 10.1016/j.jvir.2015.01.036. Epub 2015 Mar 29.

Reference Type DERIVED
PMID: 25824314 (View on PubMed)

Other Identifiers

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PEARLII

Identifier Type: -

Identifier Source: org_study_id