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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):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00778336
First received: October 22, 2008
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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


Condition
Peripheral Vascular Diseases
Thrombosis
Venous Thrombosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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:

    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:
  • 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.


Enrollment: 452
Study Start Date: January 2007
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778336

Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00778336     History of Changes
Other Study ID Numbers: PEARL
Study First Received: October 22, 2008
Results First Received: February 22, 2011
Last Updated: October 8, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014