atherosclerotic disease
Conditions
Interventions
Catheter for balloon dilatation angioplasty
The investigational device has a drug coating containing Paclitaxel on the balloon surface. When inflating the balloon, the blood vessel will be mechanical
Sponsors
Soga Yoshimitsu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Subject has symptomatic peripheral artery disease (PAD) of the native femoropopliteal artery with Rutherford classification 2, 3, and 4. (2)Subject is able to verbally acknowledge and understand the aim of this trial and the trial period and is willing and able to provide informed consent and comply with all requirements for clinical visits and assessment during the follow-up period.
Exclusion criteria
Exclusion criteria: (1)History of hemorrhagic stroke or ST-Elevation Myocardial Infarction (STEMI) within 3 months prior to enrollment (2)Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel (3)Chronic renal insufficiency with serum creatinine >2.0 mg/dL (4)Any major (e.g. cardiac, peripheral, abdominal) intervention (including in the contralateral femoral-popliteal artery) was performed within 30 days pre index procedure or is planned within 30 days post index procedure. (5)Diagnosis of bleeding diathesis or hypercoagulable state (6)Subject has an infectious disease that requires systemic treatment. (7)Subject has mental illness or coexisting mental symptoms that interfere with daily life, and has difficulty participating in the trial. (8)Subject is participating in another trial or intervention involving a medical device, and a pharmaceutical and biological drug product. (9)Life expectancy, of at least 1 year (10)Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency of the target within 12 months from procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Device success (2)Procedural success (3)Clinical success Procedural success without procedural complication (death, major target limb amputation, thrombosis of the target lesion, or Target Vessel Revascularization (TVR) prior to discharge. (4)The following endpoints will be assessed at 1 month, 6 months, 12 months, 24 months and 36 months after procedure. However, TLR, change of Rutherford classification and Ankle Brachial Index (ABI) from baseline will be also assessed at 48 months and 60 months after procedure in addition to the aforementioned evaluation period of time: -Primary and Secondary Patency;(PSVR<=2.4) -TLR -Alternative Primary and Secondary Patency based on DUS PSVR<3.0 -Change of Rutherford classification from baseline -Change in Walking Impairment Questionnaire (WIQ) -Change in QOL (EQ-5D) -Change of Ankle Brachial Index (ABI) | — |
Contacts
Public ContactKeisuke Tsugawa
MEDICO'S HIRATA INC.
Outcome results
None listed