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| Name | Class |
|---|---|
| ID3 Medical | OTHER |
| Abbott | INDUSTRY |
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To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral and/or popliteal arteries and the first 10 cm of the below-the -knee arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical Thrombectomy (JETi®) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JETi 6F and 8F Thrombectomy system | Device | To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral and/or popliteal arteries and the first 10 cm of the below-the -knee arteries. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint | The primary efficacy endpoint is technical procedural success (post Jeti) defined as restoration of impaired flow to a straight-line orthograde flow in the target vessel/bypass with near complete or complete recanalization of occluded vessel by using the JETI system prior to further additional endovascular therapy. | During index procedure |
| Primary Safety Endpoint | The primary safety endpoint is a composite of
| Up to 30 days post-index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acute device success | Defined as successful delivery of the device to the lesion | During index procedure |
| Secondary safety endpoint at discharge up to 30 days post index procedure | Secondary safety endpoint is a composite of
|
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Inclusion Criteria:
Angiographic inclusion criteria
Exclusion Criteria:
Angiographic Exclusion Criteria:
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No IPD sharing plan
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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|
| Up to 30 days |
| Sustained clinical improvement at discharge and at 30- days post-index procedure | Clinical improvement is defined as a composite of
| Hospital admission to discharge up to 30 days and at 30 days |
| Primary Patency at discharge and at 30 days post-index procedure | The primary patency is defined as a composite of
| Hospital admission to discharge up to 30 days and at 30 days |
| Freedom from TLR at discharge and at 30 days post-index procedure | TLR is defined as a reintervention to maintain or restore the patency in the target lesion. TLR is clinically-driven (CD) when the TLR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure | Hospital admission to discharge up to 30 days and at 30 days |
| Change in target limb Rutherford Classification from baseline to 30 days post-index procedure | Change in target limb Rutherford Classification from baseline to 30 days post-index procedure | Up to 30 days |
| Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure | Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure | Up to 30 days |
| Change of life quality according to the Walking Impairment Questionnaire (WIQ) from baseline to 30 days post-index procedure | Change of life quality according to the Walking Impairment Questionnaire (WIQ) from baseline to 30 days post-index procedure | Up to 30 days |
| Change of life quality according to the EQ-5D questionnaire from baseline to 30 days post-index procedure | Change of life quality according to the EQ-5D questionnaire from baseline to 30 days post-index procedure | Up to 30 days |
| Duration of hospital stay | Duration of hospital stay | Hospital admission to discharge up to 30 days |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |