Femoropopliteal Occlusive Disease
Conditions
Brief summary
Interwoven self-expandable stent is a recent endovascular method to treat complex femoropopliteal lesions trying to reach a reasonable patency and durability like in surgical bypass.
Detailed description
Stenting of the femoro-popliteal segment is indicated in case of elastic recoil, flow-limiting dissection, insufficient per- cutaneous transluminal angioplasty (PTA) or long lesion length. However, in-stent restenosis (ISR) or fracture after endovascular treatment remains a serious concern, especially for lesions of a long segment or near the knee joint. Besides the current availability of covered or drug-coated stents, there is the self-expandable bare-metal Nitinol stent which rapidly evolved during the last decade from closed-cell to open-cell and, more recently, to interwoven stents. interwoven nitinol stent design of fully connected structures facilitates a continuous but a traumatic synergy between the stent and vessel wall and hence enables axial compliance. Investigators here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropopliteal complex occlusive lesions.
Interventions
OTHERInterwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .
we here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropoliteal complex occlusive lesions.
Sponsors
Assiut University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| peak systolic velocity in centimeters per second (cm/sec) through the deployed stent in serial duplex imaging | 4 years | Crossing the lesion and deploying the stent without residual stenosis or degree of stenosis is less than 30% and assess the time the stent remains patent without re interventions. the outcome will be measured on clinical aspect and imaging aspect. Clinically ,investigators will trace the ankle brachial index (ankle systolic pressure relative to systemic systolic pressure), wound healing progress through cascade measuring of ulcer diameter in centimeters till complete healing and pain improvement depending on visual analogue score from 0 to 10.Imaging follow up, investigators will trace diseased segment diameters after intervention in millimeters and peak systolic velocity through the stent in centimeters per second. |
Countries
Egypt
Contacts
Primary Contactahmed A hussein, master of vascular surgery
Outcome results
None listed