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

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: NCT00778336
Recruitment Status : Completed
First Posted : October 23, 2008
Results First Posted : April 26, 2011
Last Update Posted : October 17, 2014
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease
Peripheral Vascular Diseases Thrombosis Venous Thrombosis

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 : Observational
Actual Enrollment : 452 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters
Study Start Date : January 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

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.

Primary Outcome Measures :
  1. Change From Baseline to Final Angiographic Results [ Time Frame: Index Procedure ( pre-endovascular treatment and post-endovascular treatment) ]

    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:

    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 value from the final value.

Secondary Outcome Measures :
  1. Rethrombosis [ Time Frame: 3 Month Follow Up ]
    The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).

  2. Description of Treatments by Thrombotic Condition [ Time Frame: Index Procedure ]
    The # of patients that were exposed to each treatment at least once in the given thrombotic condition.

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.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with peripheral thrombosis treated with a AngioJet mid-length catheter that is indicated for thrombosis removal.

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:

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): NCT00778336

Sponsors and Collaborators
Boston Scientific Corporation
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

Responsible Party: Boston Scientific Corporation Identifier: NCT00778336     History of Changes
Other Study ID Numbers: PEARL
First Posted: October 23, 2008    Key Record Dates
Results First Posted: April 26, 2011
Last Update Posted: October 17, 2014
Last Verified: October 2014

Keywords provided by Boston Scientific Corporation:
Peripheral Thrombosis
Limb Ischemia
AV Access

Additional relevant MeSH terms:
Vascular Diseases
Venous Thrombosis
Peripheral Vascular Diseases
Peripheral Arterial Disease
Embolism and Thrombosis
Cardiovascular Diseases
Arterial Occlusive Diseases