Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases
Femoropopliteal Occlusive Disease
About this trial
This is an interventional treatment trial for Femoropopliteal Occlusive Disease
Eligibility Criteria
Inclusion criteria:
- Patients with critical limb ischemia(grade 4,5&6 Rutherford classification) and patients with disabling claudications which interferes with routine activities (grade 3 Rutherford classification).
- Patients with chronic total occlusion(CTO) of femoropopliteal segment which is equal or beyond 10 centimeters length.
- Patients with recoil after transluminal angioplasty or occlusion in previously deployed stent.
- If the lesion extends to popliteal artey against knee flexion.
Exclusion criteria:
- Pediatric patients.
- Patients with isolated infra-popliteal occlusion.
- Patients with popliteal blind segment with bad runoff.
- Patients with acute thrombotic occlusions.
- Patients with previous bypass surgery in affected limb.
- Patients with aneurysmal lesion in the affected limb.
Sites / Locations
- Assiut university
Arms of the Study
Arm 1
Experimental
patients with critical and subcritical femoropopliteal arterial occlusions
patients presented with chronic ischemia in rest pain stage or ulcerative and gangrenous toes and by investigations long chronic total occlusion of femoropopliteal segment was documented may need stenting of the diseased segment especially if the lesion recoils after previous angioplasty. Nitinol interwoven stent has a unique design that achieves adherence to vessel wall and also malleability with the vessel and surrounding muscle motion so investigators predict more extended patency time with this interventional option and want to investigate this prediction using a scientific experimental pathway.