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

Completed
Conditions
Venous Thrombosis
Thrombosis
Peripheral Vascular Diseases
Registration Number
NCT00778336
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
452
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change From Baseline to Final Angiographic ResultsIndex 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
NameTimeMethod
Rethrombosis3 Month Follow Up

The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).

Description of Treatments by Thrombotic ConditionIndex Procedure

The # of patients that were exposed to each treatment at least once in the given thrombotic condition.

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