Critical Limb Ischemia
Conditions
Interventions
Drug Coating Balloon (JLL-LEG)
Standard PTA
Sponsors
Japan Lifeline Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subject is 20 years or older at the time of obtaining consent. (2) In the case of complex lesions of the femoral and iliac arteries, subject who can perform prior treatment of inflow lesions. (3) Subject with stenosis or occlusion below the popliteal arteries (Reference vessel diameter is 2 mm or more and 6 mm or less, cumulative lesion length is less than 380 mm). (4) Subject with critical limb ischemia corresponding to Rutherford categories 5 that meet the following criteria. However, in the past, endovascular treatment has been performed below the popliteal arteries, and recurrent cases with wound healing can be included. 1) SPP value is less than 40 mmHg. However, this does not apply if ischemia can be diagnosed by echo evaluation when it is judged that the SPP value is clinically invalid. 2) Needs conservative treatment for wounds or local treatment such as debridement is planned. 3) If both limbs correspond to Rutherford categories 5, subject is one limb, and can protect the target limb from wounds (hospitalization, decompression, etc.). (5) Subject is eligible for EVT. (6) Subject with a prognosis of life of 1 year or more. (7) Subject who can obtain written informed consent to voluntary prior to participating in this clinical trial.
Exclusion criteria
Exclusion criteria: (1) Subject who undergoes EVT as a pretreatment for major amputation or who is expected to cannot avoid major amputation even if EVT is performed. (2) Subject with severe heart failure. (3) Subject with untreated severe coronary artery disease. (4) Subject with severe infection. (5) Subject with ulcers on the heel. (6) Subject with inflammation extending to the sole of the foot. (7) Subject with accumulated pus in the wounds. (8) Subject with taking steroids. (9) Subject with albumin value less than 2.5 g/dl. (10) Subject with low ADL (WHO PS score of 4 or more). Except when it is caused by the underlying disease. (11) Subject with ulcers that are unlikely to becaused by lower limb ischemia, because lower limb blood flow is evaluated to be sufficiently by objective blood flow assessment (angiography, echo, etc.). (12) Subject with ulcers caused by primary diseases other than arteriosclerosis such as vasculitis. (13) Subject with major amputation on the contralateral limb. (14) Subject with Rutherford categories 6 on the contralateral limb. (15) Subject with pregnant or possibly pregnant and lactating. (16) Subject with hypersensitivity reaction to aspirin, heparin, clopidogrel or ticlopidine. (17) Subject with a history of contraindications or allergies to contrast agents. However, subject with a history of allergies are excluded when preoperative administration of steroids can prevent symptoms. (18) Subject with bleeding tendency or abnormal blood coagulation, who cannot perform emergency blood transfusion, or who is contraindicated for antiplatelet drugs. (19) Subject with stroke or transient ischemic attack (TIA) within 6 months before preoperative. (20) Subject with treatment history of abdominal aorta within 1 month before preoperative. (21) Subject who have paclitaxel-eluting stents placed on the target limbs within 1 year before preoperative.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success rate of target limb at 6 months post procedure. Treatment success is defined as the target wounds are healed without target lesion revascularization and unplanned lower limb amputation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy - Technical success rate - Initial treatment success rate - Clinical success rate of target limb [Time Frame: 30 days, 3 and 6 months post procedure] - Unplanned lower limb amputation of target limb at 6 months post procedure - Target lesion revascularization at 6 months post procedure - Patency of target limb at 6 months post procedure - Time to wound healing of target limb - Time to achievement of granulation of target wounds - Wound healing rate of target limb [Time Frame: 30 days, 3 and 6 months post procedure] - EQ-5D assessment [Time Frame: 30 days, 3 and 6 months post procedure] Safety - Mortality rate [Time Frame: 30 days, 3, 6 and 12 months post procedure] - MACE rate [Time Frame: 30 days, 3, 6 and 12 months post procedure] - MALE rate [Time Frame: 30 days, 3, 6 and 12 months post procedure] - Major amputation rate [Time Frame: 30 days, 3, 6 and 12 months post procedure] - Perioperative vascular complication rate of target limb - Perioperative puncture site complication rate of target limb - Adverse event - Clinical laboratory test (hematological test, biochemical test of blood serum chemistry, blood coagulation/fibrinolysis system test and examination of urine), Vital signs (blood pressure, pulse rate), Objective blood flow assessment (SPP, Echo) | — |
Countries
Japan
Contacts
Public ContactKoji Horikawa
Japan Lifeline Co., Ltd. Regulatory Affairs General Management Business Unit Clinical Affairs Section
Outcome results
None listed