Trial Outcomes & Findings for JETi Lower Extremity Venous Thrombosis (NCT NCT07027878)

Last Updated: 2026-04-03

Results Overview

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 assessed venous segments (including iliac, common femoral, femoral and popliteal) at that specific timepoint. Each limb can only have one modified Marder score.

Recruitment status

COMPLETED

Target enrollment

121 participants

Primary outcome timeframe

30 days

Results posted on

2026-04-03

Participant Flow

A total of 116 lower extremity deep vein thrombosis (LE DVT) subjects were registered from a real-world all-comers population across 17 sites in the United States and Europe between August 3, 2020 and July 11, 2024.

Participant milestones

Participant milestones
Measure	JETi™ Hydrodynamic Thrombectomy System Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included. JETi lower extremity venous thrombosis: The JETi System is a hydro-mechanical aspiration system, intended for the removal of intravascular thrombus. The system comprises of the JETi Catheter (6F or 8F), JETi Pump Set, JETi Saline Drive Unit (SDU), JETi Accessory Cart, JETi Suction tubing and JETi Non-Sterile Canister Set. The JETi System is designed to continuously aspirate thrombotic material into the catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.
Overall Study STARTED	116
Overall Study COMPLETED	108
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	JETi™ Hydrodynamic Thrombectomy System Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included. JETi lower extremity venous thrombosis: The JETi System is a hydro-mechanical aspiration system, intended for the removal of intravascular thrombus. The system comprises of the JETi Catheter (6F or 8F), JETi Pump Set, JETi Saline Drive Unit (SDU), JETi Accessory Cart, JETi Suction tubing and JETi Non-Sterile Canister Set. The JETi System is designed to continuously aspirate thrombotic material into the catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.
Overall Study Death	3
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	3

Baseline Characteristics

JETi Lower Extremity Venous Thrombosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JETi™ Hydrodynamic Thrombectomy System n=116 Participants Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included.
Age, Continuous	56.6 years STANDARD_DEVIATION 18.5 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	37 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Region of Enrollment United States	81 participants n=5 Participants
Region of Enrollment Germany	35 participants n=5 Participants
Source of Thrombus Embolic	36 Participants n=5 Participants
Source of Thrombus In Situ	53 Participants n=5 Participants
Source of Thrombus Unknown	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Out of 124 treated limbs images submitted to the core lab, 118 limbs were used for the primary endpoint calculation.

Outcome measures

Outcome measures
Measure	JETi™ Hydrodynamic Thrombectomy System n=118 limbs Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included.
The Primary Effective Endpoint: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction in Modified Marder Score (From Pre-JETi to Final)	84.5 percentage of limbs

PRIMARY outcome

Timeframe: 30 days

Population: All registered subjects were included in the analysis

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

Outcome measures

Outcome measures
Measure	JETi™ Hydrodynamic Thrombectomy System n=116 Participants Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included.
The Primary Safety Endpoint: Composite of JETi-related Major Adverse Events (MAEs) up to 30 Days	1.7 percentage of participants Interval 0.21 to 6.09

Adverse Events

JETi™ Hydrodynamic Thrombectomy System

Serious events: 53 serious events

Other events: 16 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	JETi™ Hydrodynamic Thrombectomy System n=116 participants at risk Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included.
Cardiac disorders Acute Myocardial Infarction	1.7% 2/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Gastrointestinal disorders Abdominal Pain Upper	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Gastrointestinal disorders Intestinal Perforation	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Gastrointestinal disorders Retroperitoneal Haematoma	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
General disorders Death	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
General disorders Systemic Inflammatory Response Syndrome	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Infections and infestations Urinary Tract Infection	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Injury, poisoning and procedural complications Fracture	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Injury, poisoning and procedural complications Road Traffic Accident	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Investigations Blood Culture Positive	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Investigations Haemoglobin Decreased	1.7% 2/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Cancer	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma Multiforme	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rhabdomyosarcoma	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Renal and urinary disorders Acute Kidney Injury	2.6% 3/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.7% 2/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	2.6% 3/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Vascular disorders Haemorrhage	2.6% 3/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Vascular disorders Hypotension	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Vascular disorders Hypovolaemic Shock	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Vascular disorders Shock Haemorrhagic	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Vascular disorders Thrombosis	12.9% 15/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Vascular disorders Vascular Stenosis	1.7% 2/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.

Other adverse events

Other adverse events
Measure	JETi™ Hydrodynamic Thrombectomy System n=116 participants at risk Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included.
Gastrointestinal disorders Diarrhoea	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Vascular disorders Hypotension	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Investigations Haemoglobin decreased	1.7% 2/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Infections and infestations Coronavirus infection	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
General disorders Pyrexia	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
General disorders Chest pain	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
General disorders Fall	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Skin and subcutaneous tissue disorders Skin laceration	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Eye disorders Visual impairment	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Vascular disorders Varicose vein	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Vascular disorders Vessel perforation	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Renal and urinary disorders Acute kidney injury	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Vascular disorders Vascular stenosis	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Vascular disorders Vascular access site haematoma	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Vascular disorders Thrombosis	5.2% 6/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
Cardiac disorders Peripheral swelling	0.86% 1/116 • 30 days All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.

Additional Information

Vinuta Rau

Abbott

Phone: + 1 408-834-0621

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Inst. may publish data/results individually from its site after any of (1) a multi-center publication is published, (2) no multicenter publication is submitted within 18months after closure of the Study, or (3) Abbott confirms there will be no multi-center publication. Inst. shall provide Sponsor with draft at least 60 days prior to submission for Sponsor review/comment. Upon request, Publication shall be delayed an additional 60 days. Due consideration will be given to Sponsor comments.
Publication restrictions are in place

Restriction type: OTHER