A Prospective Observational Registry of 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.

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Key information

Conditions

Peripheral Vascular Diseases Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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:
- complete occlusion (> 90% occlusion);
- substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);
- partial occlusion (<50% occlusion AND <3cm in length);
- 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 outcomes

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).
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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Oct 23, 2008
Registry last updated: Oct 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed