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

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

Detailed Description
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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.

Official Title
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Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

Conditions
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Peripheral Vascular Diseases, Thrombosis, Venous Thrombosis

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Limb Ischemia<br>Patients presenting with limb ischemia for treatment | |
| Deep Vein Thrombosis<br>Patients presenting with deep vein thrombosis for treatment | |
| Hemodialysis Access<br>Patients presenting with thrombosed hemodialysis access for treatment | |
| Other Thrombotic Conditions<br>Patients presenting with thrombosed conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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. | Index Procedure ( pre-endovascular treatment and post-endovascular treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rethrombosis | The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure). | 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. | Index Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Thrombosis, DVT, Limb Ischemia, AV Access, AngioJet, Thrombectomy