Investigating Efficacy and Safety of JETi® in Arterial Occlusions in FEM-POP and Prox BTK-Lesions⦠(NCT06434779) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Investigating Efficacy and Safety of JETiĀ® in Arterial Occlusions in FEM-POP and Prox BTK-Lesions (JETART)
200 participantsStarted 2024-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patient is ā„18 years
* Patient has Rutherford Classification 2,3 or 4.
* Patient has provided written informed consent and is willing to comply with study follow-up requirements.
Angiographic inclusion criteria
* De novo thrombotic occlusive lesion(s) or thrombotic re-occlusion or in-stent thrombotic occlusive lesion(s) or thrombotic occlusion of a bypass (autolog or prosthetic) occurring acute or subacute with onset of complains within \<30 days prior to first seen by investigating physician.
* Target lesion is located between the ostium of the SFA and the end of the P3 segment of the popliteal artery, tibioperoneal trunk, respectively the first 10 cm of the below the knee vessels
* Target vessel diameter ℠3 mm and ⤠8 mm and irrespective of lesion length
* Target lesion must be occlusive lesion Note: there is no limitation in lesion length
* Successful, uncomplicated crossing of the target lesion occurs when the tip of the guidewire is distal to the target lesion without the occurrence of flow-limiting dissection of perforation and is judged by visual inspection to be within the true lumen.
* A patent inflow artery free from significant stenosis (ā„50% stenosis) as confirmed by angiography.
* At least one patent native distal outflow artery to the ankle or foot, free from significant stenosis (ā„ 50 % stenosis) as confirmed by angiography.
Exclusion Criteria:
* Patients meets any contraindication for JETi mechanical thrombectomy use per IFU
* Lesioā¦