Trial Outcomes & Findings for JETi Lower Extremity Arterial Thrombosis (NCT NCT04370691)
NCT ID: NCT04370691
Last Updated: 2025-06-17
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. 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
129 participants
Primary outcome timeframe
Baseline
Results posted on
2025-06-17
Participant Flow
A total of 129 subjects with LEAT were registered across 18 sites: 62.0% (80/129) were from US sites, and 38.0% (49/129) were from non-US sites. At the time of data cut-off, all LEAT subjects had met the upper window of 30-day follow-up visit; 12-month follow-up visit is ongoing.
Participant milestones
| Measure |
JETi™ Hydrodynamic Thrombectomy System
Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System will be included.
JETi lower extremity arterial thrombosis: The JETi System is 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
|
129
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
87
|
Reasons for withdrawal
| Measure |
JETi™ Hydrodynamic Thrombectomy System
Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System will be included.
JETi lower extremity arterial thrombosis: The JETi System is 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
Pending visit
|
48
|
|
Overall Study
Have Not Reached Lower Window
|
15
|
|
Overall Study
Termination
|
14
|
|
Overall Study
Missed or Overdue
|
10
|
Baseline Characteristics
JETi Lower Extremity Arterial Thrombosis
Baseline characteristics by cohort
| Measure |
JETi™ Hydrodynamic Thrombectomy System
n=129 Participants
JETi lower extremity arterial thrombosis: Subjects who were treated with JETi™Hydrodynamic Thrombectomy System will be included.
The JETi System is 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.
|
|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
50 Participants
n=5 Participants
|
|
Acute Limb Ischemia
|
68 Participants
n=5 Participants
|
|
Acute Limb Ischemia: In-Stent thrombosis
|
13 Participants
n=5 Participants
|
|
Acute Limb Ischemia: Acute graft thrombosis
|
12 Participants
n=5 Participants
|
|
Peripheral Artery Disease with Claudication (Rutherford 1-3)
|
15 Participants
n=5 Participants
|
|
Peripheral Artery Disease with CLTI (Rutherford 4-5)
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
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% reduction
Outcome measures
| Measure |
JETi™ Hydrodynamic Thrombectomy System
n=129 Vessels
Subjects who were treated with JETi™Hydrodynamic Thrombectomy System will be included.
The JETi System is 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.
|
|---|---|
|
Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis
Grade I
|
36 Vessels
|
|
Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis
Grade II
|
41 Vessels
|
|
Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis
Grade III
|
52 Vessels
|
|
Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis
Grade II or Grade III
|
93 Vessels
|
PRIMARY outcome
Timeframe: Up to 30 days post-JETi procedurePopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
JETi-related events defined as device-related death, major amputation of the treated limb, or major bleeding up to 30 days post-JETi procedure and as adjudicated by a clinical events committee (CEC).
Outcome measures
| Measure |
JETi™ Hydrodynamic Thrombectomy System
n=129 Participants
Subjects who were treated with JETi™Hydrodynamic Thrombectomy System will be included.
The JETi System is 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.
|
|---|---|
|
Primary Safety Endpoint - Composite Rate of JETi-related MAEs
|
0 participants
Interval 0.0 to 2.82
|
Adverse Events
JETi™ Hydrodynamic Thrombectomy System
Serious events: 28 serious events
Other events: 16 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
JETi™ Hydrodynamic Thrombectomy System
n=129 participants at risk
Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System will be included.
JETi lower extremity arterial thrombosis: The JETi System is 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.
|
|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.78%
1/129 • Up to 12 months
|
|
Cardiac disorders
Angina Unstable
|
0.78%
1/129 • Up to 12 months
|
|
Cardiac disorders
Arrhythmia
|
0.78%
1/129 • Up to 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.78%
1/129 • Up to 12 months
|
|
Cardiac disorders
Cardiac Failure
|
1.6%
2/129 • Up to 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.78%
1/129 • Up to 12 months
|
|
Congenital, familial and genetic disorders
Atrial Septal Defect
|
0.78%
1/129 • Up to 12 months
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.78%
1/129 • Up to 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.78%
1/129 • Up to 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.6%
2/129 • Up to 12 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.78%
1/129 • Up to 12 months
|
|
General disorders
Chest Pain
|
2.3%
3/129 • Up to 12 months
|
|
General disorders
Death
|
3.9%
5/129 • Up to 12 months
|
|
General disorders
Fatigue
|
0.78%
1/129 • Up to 12 months
|
|
Infections and infestations
Abdominal Abscess
|
0.78%
1/129 • Up to 12 months
|
|
Infections and infestations
Coronavirus Infection
|
0.78%
1/129 • Up to 12 months
|
|
Infections and infestations
Diabetic Foot Infection
|
0.78%
1/129 • Up to 12 months
|
|
Infections and infestations
Gangrene
|
0.78%
1/129 • Up to 12 months
|
|
Infections and infestations
Infection
|
3.1%
4/129 • Up to 12 months
|
|
Infections and infestations
Osteomyelitis
|
0.78%
1/129 • Up to 12 months
|
|
Infections and infestations
Pneumonia
|
0.78%
1/129 • Up to 12 months
|
|
Infections and infestations
Sepsis
|
0.78%
1/129 • Up to 12 months
|
|
Infections and infestations
Wound Infection
|
0.78%
1/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Arterial Restenosis
|
3.9%
5/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.78%
1/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.78%
1/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Shunt Stenosis
|
0.78%
1/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
2.3%
3/129 • Up to 12 months
|
|
Investigations
Angiogram Peripheral
|
1.6%
2/129 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.78%
1/129 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Compartment Syndrome
|
0.78%
1/129 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.78%
1/129 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Cancer
|
0.78%
1/129 • Up to 12 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.78%
1/129 • Up to 12 months
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.78%
1/129 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
2/129 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.78%
1/129 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.78%
1/129 • Up to 12 months
|
|
Surgical and medical procedures
Femoral Hernia Repair
|
0.78%
1/129 • Up to 12 months
|
|
Surgical and medical procedures
Foot Amputation
|
1.6%
2/129 • Up to 12 months
|
|
Surgical and medical procedures
Limb Amputation
|
3.1%
4/129 • Up to 12 months
|
|
Surgical and medical procedures
Peripheral Revascularisation
|
1.6%
2/129 • Up to 12 months
|
|
Surgical and medical procedures
Toe Amputation
|
1.6%
2/129 • Up to 12 months
|
|
Vascular disorders
Haematoma
|
0.78%
1/129 • Up to 12 months
|
|
Vascular disorders
Haemorrhage
|
2.3%
3/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.78%
1/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Artery Occlusion
|
0.78%
1/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.78%
1/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Artery Thrombosis
|
6.2%
8/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Embolism
|
0.78%
1/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Ischaemia
|
3.9%
5/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Vascular Disorder
|
1.6%
2/129 • Up to 12 months
|
|
General disorders
Not Coded
|
1.6%
2/129 • Up to 12 months
|
Other adverse events
| Measure |
JETi™ Hydrodynamic Thrombectomy System
n=129 participants at risk
Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System will be included.
JETi lower extremity arterial thrombosis: The JETi System is 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.
|
|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/129 • Up to 12 months
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/129 • Up to 12 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/129 • Up to 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/129 • Up to 12 months
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/129 • Up to 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/129 • Up to 12 months
|
|
Congenital, familial and genetic disorders
Atrial Septal Defect
|
0.00%
0/129 • Up to 12 months
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/129 • Up to 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/129 • Up to 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/129 • Up to 12 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/129 • Up to 12 months
|
|
General disorders
Chest Pain
|
0.00%
0/129 • Up to 12 months
|
|
General disorders
Death
|
0.00%
0/129 • Up to 12 months
|
|
General disorders
Fatigue
|
0.00%
0/129 • Up to 12 months
|
|
General disorders
Peripheral Swelling
|
0.78%
1/129 • Up to 12 months
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/129 • Up to 12 months
|
|
Infections and infestations
Cellulitis
|
0.78%
1/129 • Up to 12 months
|
|
Infections and infestations
Coronavirus Infection
|
0.00%
0/129 • Up to 12 months
|
|
Infections and infestations
Diabetic Foot Infection
|
0.00%
0/129 • Up to 12 months
|
|
Infections and infestations
Gangrene
|
0.00%
0/129 • Up to 12 months
|
|
Infections and infestations
Infection
|
0.00%
0/129 • Up to 12 months
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/129 • Up to 12 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/129 • Up to 12 months
|
|
Infections and infestations
Rectal Abscess
|
0.78%
1/129 • Up to 12 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/129 • Up to 12 months
|
|
Infections and infestations
Vascular Access Site Infection
|
0.78%
1/129 • Up to 12 months
|
|
Infections and infestations
Wound Infection
|
0.00%
0/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Arterial Restenosis
|
3.1%
4/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.78%
1/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Shunt Stenosis
|
0.00%
0/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
0.78%
1/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
0.00%
0/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.78%
1/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.78%
1/129 • Up to 12 months
|
|
Investigations
Angiogram Peripheral
|
0.00%
0/129 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/129 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Compartment Syndrome
|
0.00%
0/129 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
3.9%
5/129 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/129 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Cancer
|
0.00%
0/129 • Up to 12 months
|
|
Nervous system disorders
Syncope
|
0.78%
1/129 • Up to 12 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/129 • Up to 12 months
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.00%
0/129 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/129 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/129 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.00%
0/129 • Up to 12 months
|
|
Surgical and medical procedures
Femoral Hernia Repair
|
0.00%
0/129 • Up to 12 months
|
|
Surgical and medical procedures
Foot Amputation
|
0.00%
0/129 • Up to 12 months
|
|
Surgical and medical procedures
Limb Amputation
|
0.00%
0/129 • Up to 12 months
|
|
Surgical and medical procedures
Peripheral Revascularisation
|
0.00%
0/129 • Up to 12 months
|
|
Surgical and medical procedures
Toe Amputation
|
0.00%
0/129 • Up to 12 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/129 • Up to 12 months
|
|
Vascular disorders
Haemorrhage
|
0.78%
1/129 • Up to 12 months
|
|
Vascular disorders
Hypotension
|
0.78%
1/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Artery Occlusion
|
0.00%
0/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.00%
0/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Artery Thrombosis
|
0.78%
1/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Embolism
|
0.00%
0/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/129 • Up to 12 months
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.78%
1/129 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.78%
1/129 • Up to 12 months
|
Additional Information
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