Peripheral Artery Thrombosis Clinical Trial
Official title:
JET Enhanced Thrombectomy Intervention Hong Kong Post Market Study
The JETi Hong Kong PMS 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 lower extremity peripheral vasculature. This is a post-market study that will register approximately 20 subjects at approximately 5 centers in Hong Kong. Subjects participating in this study will be followed for up to 30 days after the JETi procedure.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | February 2025 |
| Est. primary completion date | February 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Subject was treated or is expected to be treated for acute/subacute thrombosis, as determined by investigator, in the lower extremity 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 Hong Kong PMS 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 infectious agent within the past 20 days. 4. Subject with hemodialysis access thrombosis or bypass graft thrombosis |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Prince of Wales Hospital | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
Hong Kong,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | For Arterial Subjects: Clot removal grade for each JETi-treated vessel | 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. |
During the procedure | |
| Primary | For Arterial Subjects: Composite of JETi-related major adverse events (MAEs) | JETi-related major adverse events (MAEs), defined as the following JETi-related events: device-related death, major amputation of the treated limb, or major bleeding up to 30 days post registration and as adjudicated by a clinical events committee (CEC) (subject basis). | Up to 30 days post-index procedure | |
| Primary | For Venous Subjects: Percent of treated vessel(s) with = 75% venous thrombus reduction via modified Marder score (limb basis). | 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). The modified Marder score is a scoring system used for quantitative assessment of deep vein thrombosis on the basis of their venographic appearance. The modified Marder score ranges from 0 to 24, with 0 representing no thrombus and 24 representing complete thrombosis. The independent imaging core laboratory will be responsible for assessing this endpoint. | During the procedure | |
| Primary | For Venous Subjects: Composite of JETi-related major adverse events (MAEs) | JETi-related major adverse events (MAEs), defined as the following JETi-related events: device-related death, symptomatic pulmonary embolism (PE), or major bleeding up to 30 days post registration, and as adjudicated by a clinical events committee (CEC) (subject basis). | Up to 30 days post-index procedure |