JETi Peripheral Thrombectomy Registry

Study Overview
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Brief Summary
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The JETi Registry is a prospective, single-arm, multi-center study to collect real-world data on the safety, performance, and clinical benefits of the JETi® Peripheral Thrombectomy System (JETi System) for the treatment of acute/subacute thrombosis in the peripheral vasculature. This post-market study will register approximately 280 subjects at approximately 30 centers in the US and Europe. Subjects participating in this registry will be followed through their 12-month follow up visit.

Official Title
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JET Enhanced Thrombectomy Intervention Registry - JETi Registry

Conditions
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Peripheral Artery Thrombosis, Peripheral Venous Thrombosis

Intervention / Treatment
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* Device: JETi Peripheral Thrombectomy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject was treated or is expected to be treated for acute/subacute thrombosis, as determined by the investigator, in the peripheral vasculature with the JETi Hydrodynamic Thrombectomy System. Subject or legally authorized representative must provide written informed consent. Subject must be ≥ 18 years of age Exclusion Criteria: Subject has previously been registered in the JETi Registry in the last 12 months unless treated in the contralateral limb/different anatomy; patients treated in the contralateral limb/different anatomy within the last 12 months may re-enroll in the study. Subject is currently participating in another drug or device clinical investigation. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the past 20 days.

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| JETi Peripheral Thrombectomy System<br>Subjects who were treated with JETi Peripheral Thrombectomy System will be included. | Device: JETi Peripheral Thrombectomy System<br>* The JETi System is is a hydro-mechanical aspiration system, intended for the removal of intravascular thrombus. The system is comprised of the JETi Catheter (6F or 8F), JETi Pump Set, JETi Saline Drive Unit (SDU), JETi Accessory Cart, JETi Suction tubing and JETi Non-Sterile Canister Set. The JETi System is designed to continuously aspirate thrombotic material into the catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For Arterial Subjects: Clot removal grade for each JETi-treated vessel | Clot removal grade for each JETi-treated target vessel from pre-JETi angiogram to post-JETi angiogram (post-JETi thrombectomy and prior to any adjunctive therapies to treat underlying culprit lesions) per the grades. The independent imaging core laboratory will be responsible for assessing this endpoint. The rate of clot removal grade for each JETi-treated target vessel will be measured as per the Grades below: Grade I: < 50% reduction Grade II: 50- <95% reduction Grade III: 95-100% reduction | From pre-JETi angiogram/venogram to post-JETi angiogram/venogram (post-JETi thrombectomy and prior to any adjunctive therapies to treat underlying culprit lesions) | 
| For Arterial Subjects: Composite of JETi-related major adverse events (MAEs) | JETi-related events such as device-related death, major amputation of the treated limb (arterial subjects only), or major bleeding up to 30 days post-index procedure and as adjudicated by a clinical events committee (CEC). | Up to 30 days post-index procedure | 
| For Venous Subjects: Percent of treated vessel(s) with ≥ 75% venous thrombus reduction via modified Marder score |  | From pre-JETi venogram to final venogram (post-JETi AND after any/all adjunctive therapies to treat underlying culprit lesions) | 
| For Venous Subjects: Composite of JETi-related major adverse events (MAEs) | JETi-related events such as device-related death, symptomatic pulmonary embolism (PE), or major bleeding up to 30 days post-index procedure and as adjudicated by a clinical events committee (CEC). | Up to 30 days post-index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABT-CIP-10433, JETi Peripheral Thrombectomy System