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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05759819
• Other study ID #: EVT-22-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Otsuka Medical Devices Co., Ltd. Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Standard stenting
The cilostazol-coated BioMimics 3D stent on the delivery system is deployed into the target lesion.

Locations

Country	Name	City	State
Japan	Saiseikai Fukuoka General Hospital	Fukuoka City	Fukuoka
Japan	Shonan Kamakura General Hospital	Kamakura City	Kanagawa
Japan	Kokura Memorial Hospital	Kitakyushu City	Fukuoka
Japan	Daini Osaka Police Hospital	Osaka City, Osaka
Japan	Tokyo Bay Urayasu Ichikawa Medical Center	Urayasu City	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Medical Devices Co., Ltd. Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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