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Thrombectomy Device
JETi™ Hydrodynamic Thrombectomy System for Peripheral Artery Disease (JETi Trial)
N/A
Recruiting
Research Sponsored by Walk Vascular LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post-index procedure
Awards & highlights
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™ Hydrodynamic 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 Globally. Subjects participating in this Registry will be followed through their 12-month follow up visit.
Eligible Conditions
- Deep Vein Thrombosis
- Peripheral Artery Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days post-index procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post-index procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
For Arterial Subjects: Clot removal grade for each JETi-treated vessel
For Arterial Subjects: Composite of JETi-related major adverse events (MAEs)
For Venous Subjects: Composite of JETi-related major adverse events (MAEs)
Secondary study objectives
Technical Success
Trial Design
1Treatment groups
Experimental Treatment
Group I: JETi™ Hydrodynamic Thrombectomy SystemExperimental Treatment1 Intervention
Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System will be included.
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Who is running the clinical trial?
Walk Vascular LLCLead Sponsor
Abbott Medical DevicesLead Sponsor
647 Previous Clinical Trials
408,254 Total Patients Enrolled
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