Working… Menu

Registry of AngioJet Use in the Peripheral Vascular System (PEARLII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01086215
Recruitment Status : Completed
First Posted : March 15, 2010
Results First Posted : November 2, 2014
Last Update Posted : November 10, 2014
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease
Peripheral Vascular Disease Embolism and Thrombosis Venous Thrombosis

Detailed Description:

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths
Study Start Date : January 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

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 a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment

Primary Outcome Measures :
  1. Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram. [ Time Frame: Day 1 ]

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

    1. complete occlusion (>90% occlusion);
    2. substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);
    3. partial occlusion (<50% occlusion AND <3cm in length)
    4. patent (without visable thrombus or occlusion) The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic/venographic value from the final value.

  2. Rethrombosis [ Time Frame: 3 Month , 6 Month and 12 Month Follow Up ]
    The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.

Secondary Outcome Measures :
  1. Concomitant Treatments Used With the AngioJet® System [ Time Frame: Day 1 ]
    The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community population

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01086215

Show Show 36 study locations
Sponsors and Collaborators
Boston Scientific Corporation
Layout table for investigator information
Principal Investigator: Lawrence Blitz, MD Chilton Memorial Hospital
Study Director: Robert Lookstein, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Ali Amin, MD The Reading Hospital & Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boston Scientific Corporation Identifier: NCT01086215    
Other Study ID Numbers: PEARLII
First Posted: March 15, 2010    Key Record Dates
Results First Posted: November 2, 2014
Last Update Posted: November 10, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Venous Thrombosis
Peripheral Vascular Diseases
Peripheral Arterial Disease
Embolism and Thrombosis
Cardiovascular Diseases
Arterial Occlusive Diseases