JETi Peripheral Thrombectomy Registry

ID#: NCT04370691

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: March 06, 2020

End Date: March 01, 2025

Contact Information:
Vinuta Rau, PhD
+1 408-845-0864
Stacy Scribner
+1 651-756-5602
Summary: 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.
Eligibility:

Inclusion Criteria:

1. 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.

2. Subject or legally authorized representative must provide written informed consent.

3. Subject must be ≥ 18 years of age

Exclusion Criteria:

1. 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.

2. Subject is currently participating in another drug or device clinical investigation.

3. 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.
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