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):
MEDRAD, Inc.
ClinicalTrials.gov Identifier:
NCT00778336
First received: October 22, 2008
Last updated: July 9, 2012
Last verified: July 2012

October 22, 2008
July 9, 2012
January 2007
March 2010   (final data collection date for primary outcome measure)
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.

Evaluate the performance of the AngioJet midlength catheters [ Time Frame: Upon admission for procedure through 3 month follow up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00778336 on ClinicalTrials.gov Archive Site
  • 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.
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A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters
Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patient with peripheral thrombosis treated with a AngioJet mid-length catheter that is indicated for thrombosis removal.

  • Peripheral Vascular Diseases
  • Thrombosis
  • Venous Thrombosis
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
452
April 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00778336
PEARL
No
MEDRAD, Inc.
MEDRAD, Inc.
Not Provided
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
MEDRAD, Inc.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP