Evaluate the Efficacy and Safety of the Cilostazol-coated BioMimics 3D Stent System in Patients With Peripheral Arterial Occlusive Disease

Otsuka Medical Devices

Status: Active, not recruiting

Conditions: Peripheral Arterial Disease

Treatments: Device: Standard stenting

Study type: Interventional

Funder types: Industry

Identifiers

NCT05759819

EVT-22-001

Details and patient eligibility

About

An exploratory evaluation of the efficacy and safety of CLZ-BM3D for the treatment of symptomatic peripheral occlusive arterial disease of the superficial femoral artery or proximal popliteal artery

Full description

This Study demonstrate an exploratory evaluation of the efficacy and safety of CLZ-BM3D for the treatment of symptomatic peripheral occlusive arterial disease of the superficial femoral artery or proximal popliteal artery

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with an ankle-brachial index (ABI) of 0.90 or less in the target lower extremity at rest.
• Patients with stenotic lesions (target lesions) requiring treatment of SFA or PPA.
• Patients with Rutherford classification 2, 3, or 4.
• The reference vessel diameter of the target lesion is between 4 mm or more and 5 mm by operator's visual estimate.
• The total length of target lesion measure ≦50㎜ by operator's visual estimate.
• Target lesion lumen stenosis is >70% diameter stenosis by operator's visual estimate.

Exclusion criteria

• Patients with a history of surgical or endovascular treatment (including any percutaneous transluminal balloon angioplasty, stenting, atherectomy, or bypass) of the target lesion or vessel prior to enrollment in this study.

However, a history of balloon dilatoplasty with POBA is acceptable if it was performed earlier than 12 months prior to enrollment.

• Patients with a history of major amputation of the target lower extremity.
• Patients with another stenotic lesion in the target or contralateral lower extremity other than the target lesion that is judged to require surgery or endovascular treatment at the time of consent or within 12 months after the procedure.

However, if the patient has another stenotic lesion in the iliac artery other than the target lesion, treatment of the iliac artery lesion (POBA and stenting) is allowed at the time of the study procedure.

• Patients with acute coronary syndrome or stroke/cerebrovascular event within 3 months prior to obtaining consent.
• Patients with coagulopathy.
• Patients with renal insufficiencyor on dialysis.
• Patient who administered orally cilostazol within 7 days prior to the study procedure.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

CLZ-BM3D group

Experimental group

Description:

The cilostazol-coated BioMimics 3D stent on the delivery system is implanted into the target lesion and self-expands to maintain the vessel lumen diameter. Post-dilatation is performed as needed. - CLZ is released from the surface of the implanted stent.

Treatment:

Device: Standard stenting