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NCT04370691 · ClinicalTrials.gov registry record

JETi Lower Extremity Arterial Thrombosis

A clinical trial, sponsored by Abbott Medical Devices.

Completed
Registry status
129
Enrollment target

NCT04370691: Completed study, sponsored by Abbott Medical Devices.

NCT04370691 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 129 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04370691 has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
129 participants
Enrollment target

Study 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.

Primary Outcome

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% re

Interventions

  • DEVICE JETi lower extremity arterial thrombosis

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2020-03-06
Est. Completion 2024-10-09
Abbott Medical Devices

261 total trials

What the finished NCT04370691 record still lists

NCT04370691 is an observational study that tracks outcomes without assigning an intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which JETi lower extremity arterial thrombosis is the first listed.

NCT04370691 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04370691 about?

NCT04370691 is a clinical study titled "JETi Lower Extremity Arterial Thrombosis". 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 s...

What is the current status of trial NCT04370691?

This trial is currently completed. The enrollment target is 129 participants. The study started on 2020-03-06. Estimated completion is 2024-10-09.

What interventions are being tested in trial NCT04370691?

The interventions under investigation include: JETi lower extremity arterial thrombosis (DEVICE).

Who is sponsoring clinical trial NCT04370691?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04370691, the US trial registry maintained by the National Library of Medicine. NCT04370691 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.