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

NCT05759819 | Active Not Recruiting

• 1 other identifier: EVT-22-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

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

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Primary patency of 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.

  12 months

• Composite of major adverse events (MAEs) up to 12 months after the investigational 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.

  12 months

Study Arms (1)

CLZ-BM3D group

EXPERIMENTAL

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.

Device: Standard stenting

Interventions

Standard stenting DEVICE

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

CLZ-BM3D group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Medical Devices Co., Ltd. Japan: lead

Study Sites (5)

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, Japan

Location

Saiseikai Fukuoka General Hospital

Fukuoka, Fukuoka, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Location

Osaka Keisatsu Hospital

Osaka City, Osaka, Japan

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 8, 2023
• Study Start: March 10, 2023
• Primary Completion: December 5, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)