Registry of AngioJet Use in the Peripheral Vascular System

Study Overview
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Brief Summary
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The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system.

Detailed Description
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The PEARL II Registry is a prospective, multi-center, observational registry including 500 patients who meet eligibility from up to 50 sites worldwide. Patient participation will be 12 months including post procedure follow-up contact at 3, 6 and 12 months. The study duration is estimated at 36 months. A patient's treatment is determined by the treating physician based on the clinical situation and local practices. In contrast to a randomized, controlled trial, there are no pre-defined experimental interventions.

Official Title
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PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths

Conditions
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Peripheral Vascular Disease, Embolism and Thrombosis, Venous Thrombosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has been treated in the peripheral vascular system with any of the AngioJet System catheters. Patient has provided appropriate consent/authorization per the site's institutional policy and procedure. Exclusion Criteria: Patient has previously been enrolled in either the PEARL Registry or the PEARL II Registry in the last 12months.
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 a thrombotic condition 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 in Degree of Occlusion From Baseline to Final Angiogram/Venogram. | From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms/venograms, 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/venographic value from the final value. | Day 1 | 
| Rethrombosis | The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up. | 3 Month , 6 Month and 12 Month Follow Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concomitant Treatments Used With the AngioJet® System | The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure | Day 1 |