BRAVE trial

JRCT ID: jRCTs032220289

Registered date:01/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Symptomatic arteriosclerosis obliterans
• Date of first enrollment: 28/09/2022
• Target sample size: 320
• Study type: Interventional

Intervention(s)

Use of antiplatelet drugs
BioMimics 3D BMS treatment group:
1)Cilostazol
It is administered for 24 months after stent implantation.
Cilostazol is started at a small dose (daily dose: 50 mg x 2 doses) and maintained at a daily dose of 200mg in principle. The dosage may be adjusted according to the patient's symptoms.
*For patients receiving cilostazol before the start of the study, 200mg of cilostazol may be administered at the discretion of the treating physician from the first time.

2)Other antiplatelet agents
Aspirin or thienopyridine antiplatelet agents are given for at least 30 days after stenting.
The type, quantity, and duration of antiplatelet drugs should be left to the discretion of the physician.

ELUVIA DES treatment group:
As a rule, dual antiplatelet therapy (DAPT) is performed for at least 60 days after stenting.
In addition, the type, quantity, and duration of antiplatelet drugs should be left to the discretion of the physician.
Cilostazol should not be administered.

Outcome(s)

• Primary Outcome: Primary patency rates of target lesions at 12 months after the procedure.

Secondary Outcome

(1) Safety
(2) Bleeding event according to BARC criteria (BARC 3,5 and 2,3,5)
(3) Cumulative event free rate of composite end points (MAEs) and each component of MAEs at 30 days, 12 months, and 24 months after the procedure
- Death
- Lower limb amputation
- Surgical transition
- Revascularization (CD-TLR)
(4) Incidence of stent thrombosis at 30 days, 12 months, and 24 months after the procedure
(5) Primary patency of target lesions at 24 months after the procedure
(6) Changes in resting ABI
(7) Change in Rutherford classification

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients aged 20 years or older
(2) Patients with target lesions in the symptomatic superficial femoral artery (SFA) or proximal popliteal artery (PA) requiring endovascular treatment (any new lesion, any restenotic lesion) *
(3) Patients with target lesion lengths <25cm
(4) Patients with a Rutherford class of 2-5
(5) Patients with control vessel diameters >=4 mm and =<6 mm (visualized by angiography)
(6) Patients in whom patent inflow artery was confirmed (stenosis rate < 50% visually)
(7) Patients with at least one patent vessel below the knee on initial angiography
(8) Patients for whom written informed consent is obtained from the person
(9) Patients willing to cooperate with all follow-up assessments specified in the study protocol
*lower limb extremity lesion: Iliac artery is not included and popliteal artery territory is up to P1.

Exclude criteria

(1) Patients considered to have a life expectancy of less than 2 years
(2) Female patients who are pregnant or are planning to become pregnant
(3) Patients who have had or have had a hemorrhagic stroke within 3 months before the procedure
(4) Patients treated with thrombolysis within 30 days before the procedure
(5) Patients who underwent surgery (surgery, endovascular treatment, etc.) that may affect the evaluation of this clinical study within 15 days before the procedure or who were scheduled within 30 days after this clinical study procedure
(6) Patients with drug allergy or contraindications to antiplatelet drugs and cilostazol (or similar drugs) required in this clinical study.
(7) Patients with bleeding diathesis (hemophilia, capillary fragility, intracranial hemorrhage, gastroint estinal hemorrhage, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.)
(8) Patients with congestive heart failure *
(9) Patients with contrast allergy
(10)Patients currently participating in or scheduled to participate in other clinical trials
(11)Patients with a lesion in which appropriate stenting cannot be performed or the stent cannot be fully expanded with a balloon
(12)Patients with lesions in the aneurysm or proximal or distal to the aneurysm
(13)Patients require a radial or brachial approach for stenting
(14)Patients with obvious hypersensitivity to nitinol or its constituents (nickel, titanium) or tantalum
(15) Patients diagnosed with hypersensitivity to paclitaxel or its related substances
(16) Patients are in cancer treatment with paclitaxel
(17) Patients diagnosed with hypersensitivity to acrylic polymers, fluoropolymers, or their individual constituents
(18) Patients taking direct-acting oral anticoagulants (DOAC).
(19) Patients with prior stent treatment in the lower extremities with target lesions
(20) Patients treated with DCB of the target lesion within 30 days
(21) Patients who are deemed ineligible for this clinical study at the discretion of a physician
*Heart failure in this study is defined as NYHA2 or more or ejection fraction (EFs) 35% or less.

Related Information

• Primary Sponsor: Nakamura Masato
• Source(s) of Monetary Support: Otsuka Medical Devices Co., Ltd.,Boston Scientific Corporation