JETi Lower Extremity Venous Thrombosis

Active, not recruiting

• Conditions: Venous Thrombosis

• Registration Number: NCT07027878
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The JETi Registry is a prospective, single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the peripheral vasculature. This is a post-market study that 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-06
• Primary Completion: 2024-08-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of JETi-related major adverse events (MAEs)	Up to 30 days post-index procedure	Composite of JETi-related MAEs up to 30 days post-JETi procedure, defined as the following JETi-related events adjudicated by a clinical event committee (CEC): 1. death,; 2. symptomatic pulmonary embolism (PE),; 3. major bleeding; 4. re-thrombosis of JETi-treated vessel(s).
Percent of treated vessel(s) with ≥ 75% venous thrombus reduction via modified Marder score. The independent imaging core laboratory will be responsible for assessing this endpoint.	Perioperative/Periprocedural	Percent of treated vessel(s) with ≥ 75% venous thrombus reduction via modified Marder from pre-JETi venogram to final venogram (post-JETi AND after any/all adjunctive therapies to treat underlying culprit lesions)

Trial Locations

Locations (30)

HonorHealth; 🇺🇸 Scottsdale, Arizona, United States

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States

PIH Good Samaritan; 🇺🇸 Los Angeles, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Stanford University Hospital and Clinics; 🇺🇸 Palo Alto, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

ClinRé; 🇺🇸 Thornton, Colorado, United States

St. Mary Medical Center; 🇺🇸 Hobart, Indiana, United States

Midwest Cardiovascular Research Foundation; 🇺🇸 Davenport, Iowa, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

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