Arterial Thrombosis
Conditions
Keywords
ABT-CIP-10433, Arterial Thrombosis, Lower Extremity
Brief summary
The JETi Registry is a prospective, single-arm, multi-center study to collect real-world data on the safety, performance, and clinical benefits of the JETi™ Hydrodynamic Thrombectomy System (JETi System) for the treatment of acute/subacute thrombosis in the peripheral vasculature. This post-market study 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.
Interventions
DEVICEJETi 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.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis | Baseline | 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 |
| Primary Safety Endpoint - Composite Rate of JETi-related MAEs | Up to 30 days post-JETi procedure | 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). |
Countries
Australia, Canada, Germany, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| JETi™ Hydrodynamic Thrombectomy System 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. | 129 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Have Not Reached Lower Window | 15 |
| Overall Study | Missed or Overdue | 10 |
| Overall Study | Pending visit | 48 |
| Overall Study | Termination | 14 |
Baseline characteristics
| Characteristic | JETi™ Hydrodynamic Thrombectomy System |
|---|---|
| Acute Limb Ischemia | 68 Participants |
| Acute Limb Ischemia: Acute graft thrombosis | 12 Participants |
| Acute Limb Ischemia: In-Stent thrombosis | 13 Participants |
| Age, Continuous | 66.9 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 52 Participants |
| Peripheral Artery Disease with Claudication (Rutherford 1-3) | 15 Participants |
| Peripheral Artery Disease with CLTI (Rutherford 4-5) | 21 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Others | 3 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 50 Participants |
| Race/Ethnicity, Customized White | 64 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 129 |
| other Total, other adverse events | 16 / 129 |
| serious Total, serious adverse events | 28 / 129 |
Outcome results
Primary
Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis
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
Time frame: Baseline
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| JETi™ Hydrodynamic Thrombectomy System | Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis | Grade I | 36 Vessels |
| JETi™ Hydrodynamic Thrombectomy System | Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis | Grade II | 41 Vessels |
| JETi™ Hydrodynamic Thrombectomy System | Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis | Grade III | 52 Vessels |
| JETi™ Hydrodynamic Thrombectomy System | 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
Primary Safety Endpoint - Composite Rate of JETi-related MAEs
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).
Time frame: Up to 30 days post-JETi procedure
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JETi™ Hydrodynamic Thrombectomy System | Primary Safety Endpoint - Composite Rate of JETi-related MAEs | 0 participants |