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

Boston Scientific Corporation452 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

452

Conditions

Peripheral Vascular Diseases Thrombosis Venous Thrombosis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change From Baseline to Final Angiographic Results

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.

Time frame: Index Procedure ( pre-endovascular treatment and post-endovascular treatment)

Secondary Outcomes

Rethrombosis

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

Time frame: 3 Month Follow Up

Description of Treatments by Thrombotic Condition

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

Time frame: Index Procedure

Data from ClinicalTrials.gov

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