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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JETiâ„¢ Hydrodynamic Thrombectomy System | Subjects who were treated with JETiâ„¢ Hydrodynamic Thrombectomy System were included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JETi lower extremity venous thrombosis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Effective Endpoint: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction in Modified Marder Score (From Pre-JETi to Final) | 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. | 30 days |
| The Primary Safety Endpoint: Composite of JETi-related Major Adverse Events (MAEs) up to 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 | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects of all genders from the patient population undergoing percutaneous treatment of thrombosis in the peripheral vascular system will be enrolled in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Scottsdale | Arizona | 85258 | United States | ||
| Arkansas Heart Hospital |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | JETiâ„¢ Hydrodynamic Thrombectomy System | Subjects who were treated with JETiâ„¢ 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2024 | May 14, 2025 |
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|
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| PIH Good Samaritan | Los Angeles | California | 90017 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90095 | United States |
| Stanford University Hospital and Clinics | Palo Alto | California | 94305 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| ClinRé | Thornton | Colorado | 80023 | United States |
| St. Mary Medical Center | Hobart | Indiana | 46342 | United States |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Southoast Hospital | Fall River | Massachusetts | 02740 | United States |
| Henry Ford Detroit | Detroit | Michigan | 48202 | United States |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44195 | United States |
| Ascension St. John Jane Phillips | Bartlesville | Oklahoma | 74006 | United States |
| Hightower Clinical | Oklahoma City | Oklahoma | 73102 | United States |
| Hendrick Medical Center | Abilene | Texas | 79601 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | United States |
| Royal Perth Hospital | Perth | 6000 | Australia |
| Hôpital Saint-François d'Assise | Québec | Quebec | G1L 3L5 | Canada |
| University Hospital Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
| Marien Hospital Herne | Herne | North Rhine-Westphalia | 44625 | Germany |
| Klinikum Hochsauerland | Arnsberg | 59759 | Germany |
| Evangelisches Krankenhaus Königin Elisabeth Herzberge | Berlin | 10365 | Germany |
| Sankt Gertrauden Krankenhaus | Berlin | 10713 | Germany |
| Medizinische Einrichtungen der Universität zu Köln | Cologne | 50937 | Germany |
| Universitätsklinikum Giessen | Giessen | 35392 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | JETiâ„¢ Hydrodynamic Thrombectomy System | Subjects who were treated with JETiâ„¢ Hydrodynamic Thrombectomy System were included. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Source of Thrombus | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Effective Endpoint: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction in Modified Marder Score (From Pre-JETi to Final) | 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. | Out of 124 treated limbs images submitted to the core lab, 118 limbs were used for the primary endpoint calculation. | Posted | Number | percentage of limbs | 30 days | limbs | limbs |
|
|
| ||||||||||||||||||||||||||
| Primary | The Primary Safety Endpoint: Composite of JETi-related Major Adverse Events (MAEs) up to 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 | All registered subjects were included in the analysis | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days |
|
|
30 days
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JETiâ„¢ Hydrodynamic Thrombectomy System | Subjects who were treated with JETiâ„¢ Hydrodynamic Thrombectomy System were included. | 3 | 116 | 53 | 116 | 16 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Retroperitoneal Haematoma | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Death | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Systemic Inflammatory Response Syndrome | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
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| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
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| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
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| Blood Culture Positive | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Haemoglobin Decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
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| Glioblastoma Multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
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| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
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| Rhabdomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypovolaemic Shock | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Shock Haemorrhagic | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Vascular Stenosis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Peripheral swelling | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Coronavirus infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Fall | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Skin laceration | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA (27.1) | Systematic Assessment |
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| Varicose vein | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Vessel perforation | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
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| Vascular stenosis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Vascular access site haematoma | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (27.1) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vinuta Rau | Abbott | + 1 408-834-0621 | vinuta.rau@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2024 | Jan 19, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Unknown |
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