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

NCT ID: NCT05759819

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-10
• Study Completion Date: 2026-12-31

Brief Summary

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

Detailed 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

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CLZ-BM3D group

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.

Group Type: EXPERIMENTAL

Standard stenting

Intervention Type: DEVICE

The cilostazol-coated BioMimics 3D stent on the delivery system is deployed into the target lesion.

Interventions

Standard stenting

The cilostazol-coated BioMimics 3D stent on the delivery system is deployed into the target lesion.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Medical Devices Co., Ltd. Japan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, Japan

Saiseikai Fukuoka General Hospital

Fukuoka, Fukuoka, Japan

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Osaka Keisatsu Hospital

Osaka City, Osaka, , Japan

Countries

Japan

Other Identifiers

EVT-22-001

Identifier Type: -

Identifier Source: org_study_id