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An Exploratory Study to Evaluate the Efficacy and Safety of the Cilostazol-Coated BioMimics 3D Stent System in Patients with Peripheral Occlusive Arterial Disease (Study Protocol Number: EVT-22-001)

Exploratory study of CLZ-BM3D in patients with peripheral occlusive arterial disease

Nakamura Masato

Toho University Ohashi Medical Center

2-22-36, Ohashi, Meguro-ku, Tokyo 153-8515, Japan

OtsukaRegistry-CT@otsuka.jp

Ishinabe Kentaro

Otsuka Medical Devices Co., Ltd.

Shinagawa Grand Central Tower 13F 2-16-4, Konan, Minato-ku, Tokyo 108-0075, Japan

+81-3-6361-7459

OtsukaRegistry-CT@otsuka.jp

Not Recruiting

Mar. 01, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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 =<50mm by operator's visual estimate.
- Target lesion lumen stenosis is >70% diameter stenosis by operator's visual estimate.

- 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.

Both

Patients with peripheral occlusive arterial disease

Using standard stenting techniques, a self-expanding stent made of a nickel-titanium alloy coated with cilostazol and a polymer is deployed into the target lesion.Cilostazol is released from the surface of the implanted stent.

Primary patency of the stent at 12 months after the investigational procedure
Loss of primary patency of the stent is determined as any of the following cases.
- The case as the peak systolic velocity ratio (PSVR) exceeds 2.4
- The case as the subject had a CDTLR.
- The case as the angiography revealed > 50% lumen diameter stenosis.

Combined incidence of serious adverse events (MAEs) up to 12 months after the study procedure.
MAE is defined as:
- All death within 30 days after the study procedure.
- Major amputation of target lower extrimity.
- Clinically driven target lesion revascurarization.

+81-93-511-2000

Jan. 24, 2023

No

none