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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Standard stenting

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

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Osaka City, Osaka, Japan
    • Osaka Keisatsu Hospital
  • Chiba
    • Urayasu City, Chiba, Japan
      • Tokyo Bay Urayasu Ichikawa Medical Center
  • Fukuoka
    • Fukuoka City, Fukuoka, Japan
      • Saiseikai Fukuoka General Hospital
    • Kitakyushu City, Fukuoka, Japan
      • Kokura Memorial Hospital
  • Kanagawa
    • Kamakura City, Kanagawa, Japan
      • Shonan Kamakura General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Standard stenting; The cilostazol-coated BioMimics 3D stent on the delivery system is deployed into the target lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): December 5, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 26, 2023
• First Submitted That Met QC Criteria: February 26, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: EVT-22-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No