Lower Extremity Artery Disease
Conditions
Interventions
Stent group: Investigational device is implanted after pre-dilation with a balloon dilation catheter.
Control group: The lesion is dilated with a balloon dilation catheter.
Sponsors
Hasebe Terumitsu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (pre-enrollment) 1) Patient is 18 years or older at the time that informed consent is obtained. 2) Patient has atherosclerotic LEAD with the target lesion(s) of the unilateral lower limb, and meets the following conditions, a-f, at pre-enrollment. a. Rutherford classification in the affected limb: Category 4 or 5 b. The reference vessel diameter is >= 2.0 to == 70% by contrast-enhanced computed tomography (CT). 4) Target lesion can be stented without covering the ostium of any patent major branch. 5) Patient has good runoff. 6) Patient does not have femoropopliteal lesions (> 50% stenosis), or completed the treatment 30 days or more before obtaining informed consent. 7) Male or female patient with childbearing potential agrees with contraception using medically approved methods* during the study. * Medically approved methods: Use of intrauterine device, double barrier method (combination of condom and diaphragm with spermicide), contraceptive implant, and oral contraceptive pills, cases where men are confirmed to be azoospermic after vasectomy, or the like. 8) Patient completely understands the purpose of this trial and provides written informed consent for participation in this trial. (enrollment) 1) Patient has reference vessel diameter of >= 2.0 to =< 4.0 mm and lesion length of =< 140 mm measured by angiography during the procedure (when the lesion needs to be treated with two stents that overlap, both stents must be of the same diameter). 2) Patient in whom it was confirmed that the guidewire had passed through the target lesion. The retrograde approach is allowable, but the investigational device must be delivered anterogradely. 3) Patient has a stenosis rate exceeding 70% of the target lesion observed by angiography during the procedure. 4) Patient has a target lesion that can be stented without covering the ostium of any patent major branch, as observed by angiography during the procedure.
Exclusion criteria
Exclusion criteria: (pre-enrollment) 1) Patient is not expected to survive for one year or longer at the time that informed consent is obtained. 2) Patient has a history of stroke, myocardial infarction, or receiving thrombolytic therapy within three months before obtaining informed consent. 3) Patient has a stent implanted in the target vessel or has an aneurysm. 4) Patient had or will have the target lower limb amputated. 5) Sufficient expansion cannot be expected in the patient due to severe calcified lesions. 6) Patient received other treatments (bypass surgery, atherectomy, cutting balloon, reentry device, laser, and radiotherapy) to the target vessel(s). 7) Patient has renal failure with estimated glomerular filtration rate (eGFR) of == 600 x 10^3/microL. 9) Patient has allergy to stents or materials of stent components. 10) Patient cannot receive pre-operative premedication due to allergy to iodine contrast agents. 11) Patient has been diagnosed with hypersensitivity to heparin. 12) Patient is on a high dose of steroid or on immunosuppressive therapy. 13) Patient has been diagnosed with New York Heart Association (NYHA) class IV heart failure. 14) Patient has any of the following conditions or diseases: - Serious thyroid disease - Poorly controlled diabetes mellitus - Symptomatic coronary artery disease - On sodium-glucose cotransporter-2 (SGLT-2) inhibitors - Non-atherosclerotic disease (e.g., vasculitis, Buerger's disease, embolism) - Acute thrombus occlusion - Needs or is on hemodialysis - Active bacteremia or sepsis - Body mass index (BMI) 50%) observed by angiography during the procedure. 2) It is difficult to keep the patient at rest or to continue treatment due to procedure complications, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target limb amputation above the ankle joint, vascular occlusion, clinically-driven TLR, and avoidance of binary restenosis at 12 months post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety endpoint: Death within 30 days post-procedure, occurrence of distal embolization and with or without procedure complications at discharge, length of stay post-operation At 12 months post procedure: survival rate, stent fracture rate, occurrence of stent thrombosis, avoidance of major reintervention and unscheduled amputation of the lower limb. 2) Efficacy endpoint: Procedural success rate, primary patency rate and assisted primary patency rate, numerical rating scale (NRS), wound assessment (WIfI classification), Rutherford classification, ankle brachial pressure index (ABI), and skin perfusion pressure (SPP) | — |
Contacts
Public ContactYukihisa Ogawa
Tokai University Hachioji Hospital
Outcome results
None listed