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SOL JAPAN Clinical Trial: Safety and Efficacy Study of BP-DPC18 for the treatment of Femoropopliteal Artery Lesions in Japan (SOL JAPAN)

Safety and Efficacy Study of BP-DPC18 for the treatment of Femoropopliteal Artery Lesions in Japan (SOL JAPAN)

Soga Yoshimitsu

Kokura Memorial Hospital

3-2-1 Asano, Kokura kita-ku,Kitakyushu-city,Fukuoka

soga@circulation.jp

Tsugawa Keisuke

MEDICO'S HIRATA INC.

3-8-8EDOBORI, NISHI-KU, OSAKA 550-0002

+81-6-6443-2288

luminor@medicos-hirata.co.jp

Complete

Mar. 01, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(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.

(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.

Both

atherosclerotic disease

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 mechanically expanded and Paclitaxel contained in the drug coating will be released to the vessel wall. Paclitaxel released to the vessel wall will reduce vessel restenosis by inhibiting neointimal hyperplasia.

Primary patency of the target within 12 months from procedure.

(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)

+81-93-511-2000

Jan. 07, 2021

No

none