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NCT07027878: JETiRegistry

JETi Lower Extremity Venous Thrombosis

Completed Results posted Last updated 3 April 2026
What this trial tests

trial testing JETi lower extremity venous thrombosis in Venous Thrombosis in 121 participants. Completed in 16 July 2025.

Timeline
3 August 2020
Primary endpoint
1 August 2024
16 July 2025

Quick facts

Lead sponsorAbbott Medical Devices
StatusCompleted
Study typeOBSERVATIONAL
Enrollment121
Start date3 August 2020
Primary completion1 August 2024
Estimated completion16 July 2025
Sites30 locations across Germany, Canada, United States, Australia

Drugs / interventions tested

Conditions studied

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Venous Thrombosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Primary Effective Endpoint: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction in Modified Marder Score (From Pre-JETi to Final) Primary · 30 days

The percent of treated vessel(s) with ≥ 75% venous thrombus reduction from pre-JETi venogram to final venogram (post-JETi and after any/all adjunctive therapies to treat underlying culprit lesions) via modified Marder score. Marder Score Reduction is calculated using the formula below: \[(Pre-JETi Marder Score - final Marder Score) / Pre-JETi Marder Score\] x 100. Modified Marder Score is a calculation based on summation of gradient thrombus burden at the following venous segments: iliac, common femoral, femoral and popliteal. Modified Marder score is based on total score of all imaged and a

GroupValue95% CI
JETi™ Hydrodynamic Thrombectomy System84.5
The Primary Safety Endpoint: Composite of JETi-related Major Adverse Events (MAEs) up to 30 Days Primary · 30 days

The composite of JETi-related MAEs (death, symptomatic pulmonary embolism (PE), major bleeding, or re-thrombosis of JETi-treated vessel(s) up to 30 days post-JETi procedure for subjects treated for lower extremity DVT and as adjudicated by a CEC

GroupValue95% CI
JETi™ Hydrodynamic Thrombectomy System1.70.21 – 6.09

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

JETi™ Hydrodynamic Thrombectomy System
Serious: 53/116 (46%)
Deaths: 3/116

Serious adverse events (29 terms)

ReactionSystemJETi™ Hydrodynamic Thrombe…
ThrombosisVascular disorders
Acute Kidney InjuryRenal and urinary disorders
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders
HaemorrhageVascular disorders
Acute Myocardial InfarctionCardiac disorders
Haemoglobin DecreasedInvestigations
PneumothoraxRespiratory, thoracic and mediastinal disorders
Vascular StenosisVascular disorders
Abdominal Pain UpperGastrointestinal disorders
Gastrointestinal HaemorrhageGastrointestinal disorders
Intestinal PerforationGastrointestinal disorders
Retroperitoneal HaematomaGastrointestinal disorders
DeathGeneral disorders
Systemic Inflammatory Response SyndromeGeneral disorders
Urinary Tract InfectionInfections and infestations
FractureInjury, poisoning and procedural complications
Post Procedural HaemorrhageInjury, poisoning and procedural complications
Road Traffic AccidentInjury, poisoning and procedural complications
Blood Culture PositiveInvestigations
Pain In ExtremityMusculoskeletal and connective tissue disorders
Endometrial CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma MultiformeNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)
RhabdomyosarcomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
DyspnoeaRespiratory, thoracic and mediastinal disorders
Other adverse events (17 terms — click to expand)

ReactionSystemJETi™ Hydrodynamic Thrombe…
ThrombosisVascular disorders
Haemoglobin decreasedInvestigations
Peripheral swellingCardiac disorders
NasopharyngitisRespiratory, thoracic and mediastinal disorders
Coronavirus infectionInfections and infestations
Chest painGeneral disorders
FallGeneral disorders
Skin lacerationSkin and subcutaneous tissue disorders
Visual impairmentEye disorders
Varicose veinVascular disorders
Vessel perforationVascular disorders
Acute kidney injuryRenal and urinary disorders
Vascular stenosisVascular disorders
Vascular access site haematomaVascular disorders
DiarrhoeaGastrointestinal disorders
HypotensionVascular disorders
PyrexiaGeneral disorders

Most-reported serious reactions: Thrombosis, Acute Kidney Injury, Pulmonary Embolism, Haemorrhage, Acute Myocardial Infarction, Haemoglobin Decreased, Pneumothorax, Vascular Stenosis.

Data from ClinicalTrials.gov NCT07027878 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Venous Thrombosis

Currently open trials in the same condition.

Other Abbott Medical Devices trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07027878.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing