Trial Outcomes & Findings for JETi Hong Kong Post Market Study (PMS) (NCT NCT06340763)

Last Updated: 2025-12-16

Results Overview

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 (vessel basis). 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% reduction.

Recruitment status

COMPLETED

Target enrollment

12 participants

Primary outcome timeframe

During the procedure

Results posted on

2025-12-16

Participant Flow

A total of 12 subjects were registered in the JETi Hong Kong PMS across 3 sites in Hong Kong between August 7, 2024 and January 24, 2025.

Participant milestones

Participant milestones
Measure	JETi Hydrodynamic Thrombectomy System Subject was treated or is expected to be treated for acute/subacute thrombosis in the peripheral vasculature with the JETi Hydrodynamic Thrombectomy System.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

JETi Hong Kong Post Market Study (PMS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JETi Hydrodynamic Thrombectomy System n=12 Participants Subject was treated or is expected to be treated for acute/subacute thrombosis in the peripheral vasculature with the JETi Hydrodynamic Thrombectomy System.
Age, Continuous	68.9 Year STANDARD_DEVIATION 13.8 • n=6 Participants
Sex: Female, Male Female	6 Participants n=6 Participants
Sex: Female, Male Male	6 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	11 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants
Race (NIH/OMB) White	1 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Intended Vasculature Artery	7 Participants n=6 Participants
Intended Vasculature Vein	2 Participants n=6 Participants
Intended Vasculature Arteriovenous	3 Participants n=6 Participants
Diagnosis Acute Limb Ischemia	6 Participants n=6 Participants
Diagnosis Peripheral Artery Disease with Claudication (Rutherford 1-3)	1 Participants n=6 Participants
Diagnosis Hemodialysis Access: AV Fistula Thrombosis	2 Participants n=6 Participants
Diagnosis Hemodialysis Access: AV Graft Thrombosis	1 Participants n=6 Participants
Diagnosis Deep Vein Thrombosis	2 Participants n=6 Participants

PRIMARY outcome

Timeframe: During the procedure

Population: The number of participants analyzed includes arterial and arteriovenous subjects who had available data.

Outcome measures

Outcome measures
Measure	JETi Hydrodynamic Thrombectomy System n=9 Vessels Subject was treated or is expected to be treated for arterial or arteriovenous thrombosis with the JETi Hydrodynamic Thrombectomy System. JETi Hydrodynamic Thrombectomy System: The JETi Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi Catheter, JETi Pump Set, and JETi Saline Drive Unit (SDU), accessory cart, suction tubing, and non-sterile canister set. The JETi System is designed to simultaneously deliver a stream of high-pressure saline via a displacement pump to the distal tip of the JETi Catheter, while aspirating thrombotic material macerated by the saline stream.
Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel Grade II	2 Vessels
Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel Grade I	2 Vessels
Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel Grade III	5 Vessels

PRIMARY outcome

Timeframe: Up to 30 days post-index procedure

Population: The number of participants analyzed includes arterial and arteriovenous subjects who had available data.

JETi-related major adverse events (MAEs), defined as the following JETi-related events adjudicated by a clinical events committee (CEC) (subject basis): death, major amputation of the treated limb, or major bleeding.

Outcome measures

Outcome measures
Measure	JETi Hydrodynamic Thrombectomy System n=10 Participants Subject was treated or is expected to be treated for arterial or arteriovenous thrombosis with the JETi Hydrodynamic Thrombectomy System. JETi Hydrodynamic Thrombectomy System: The JETi Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi Catheter, JETi Pump Set, and JETi Saline Drive Unit (SDU), accessory cart, suction tubing, and non-sterile canister set. The JETi System is designed to simultaneously deliver a stream of high-pressure saline via a displacement pump to the distal tip of the JETi Catheter, while aspirating thrombotic material macerated by the saline stream.
Primary Safety Endpoint - For Arterial and Arteriovenous Subjects: Composite of JETi-related Major Adverse Events (MAEs)	0 Participants

PRIMARY outcome

Timeframe: During the procedure

Population: The number of participants analyzed includes venous subjects who had available data.

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 (limb basis). If no adjunctive therapies or devices are used after JETi, post-JETi score is also final score.

Outcome measures

Outcome measures
Measure	JETi Hydrodynamic Thrombectomy System n=2 Vessels Subject was treated or is expected to be treated for arterial or arteriovenous thrombosis with the JETi Hydrodynamic Thrombectomy System. JETi Hydrodynamic Thrombectomy System: The JETi Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi Catheter, JETi Pump Set, and JETi Saline Drive Unit (SDU), accessory cart, suction tubing, and non-sterile canister set. The JETi System is designed to simultaneously deliver a stream of high-pressure saline via a displacement pump to the distal tip of the JETi Catheter, while aspirating thrombotic material macerated by the saline stream.
Primary Effectiveness Endpoint - For Venous Subjects: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction Via Modified Marder Score (Limb Basis).	1 Vessels

PRIMARY outcome

Timeframe: Up to 30 days post-index procedure

Population: The number of participants analyzed includes venous subjects who had available data.

JETi-related major adverse events (MAEs), defined as the following JETi-related events adjudicated by a clinical events committee (CEC): death, symptomatic pulmonary embolism (PE), major bleeding, or re-thrombosis of JETi-treated vessel(s).

Outcome measures

Outcome measures
Measure	JETi Hydrodynamic Thrombectomy System n=2 Participants Subject was treated or is expected to be treated for arterial or arteriovenous thrombosis with the JETi Hydrodynamic Thrombectomy System. JETi Hydrodynamic Thrombectomy System: The JETi Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi Catheter, JETi Pump Set, and JETi Saline Drive Unit (SDU), accessory cart, suction tubing, and non-sterile canister set. The JETi System is designed to simultaneously deliver a stream of high-pressure saline via a displacement pump to the distal tip of the JETi Catheter, while aspirating thrombotic material macerated by the saline stream.
Primary Safety Endpoint - For Venous Subjects: Composite of JETi-related Major Adverse Events (MAEs)	0 Participants

Adverse Events

JETi Hydrodynamic Thrombectomy System

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	JETi Hydrodynamic Thrombectomy System n=12 participants at risk Subject was treated or is expected to be treated for acute/subacute thrombosis in the peripheral vasculature with the JETi Hydrodynamic Thrombectomy System.
Infections and infestations Endocarditis	8.3% 1/12 • Number of events 1 • From enrollment until end of follow-up, up to 30 days

Other adverse events

Adverse event data not reported

Additional Information

Vinuta Rau

Abbott

Phone: (408)845-0864

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER