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)

Otsuka Medical Devices Co., Ltd.0 sites24 target enrollmentStarted: March 10, 2023Last updated: February 5, 2025

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor: Otsuka Medical Devices Co., Ltd.
Enrollment: 24
Primary Endpoint: Primary patency of the stent at 12 months after the investigational procedure

Study Overview Study Design Eligibility Criteria Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional
Allocation: Single Arm Study
Intervention Model: Single Assignment
Primary Purpose: Treatment Purpose
Masking: Open(masking Not Used)

Eligibility Criteria

Ages: 18age old over to No limit (—)
Sex: All

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
•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.

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.

Outcomes

Primary Outcomes

Primary patency of the stent at 12 months after the investigational procedure

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

Otsuka Medical Devices Co., Ltd.

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