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

Primary Purpose

Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Standard stenting
Sponsored by
Otsuka Medical Devices Co., Ltd. Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tokyo Bay Urayasu Ichikawa Medical CenterRecruiting
  • Saiseikai Fukuoka General HospitalRecruiting
  • Kokura Memorial HospitalRecruiting
  • Shonan Kamakura General HospitalRecruiting
  • Daini Osaka Police HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CLZ-BM3D group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2023
Last Updated
July 20, 2023
Sponsor
Otsuka Medical Devices Co., Ltd. Japan
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1. Study Identification

Unique Protocol Identification Number
NCT05759819
Brief Title
Evaluate the Efficacy and Safety of the Cilostazol-coated BioMimics 3D Stent System in Patients With Peripheral Arterial Occlusive Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Medical Devices Co., Ltd. Japan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CLZ-BM3D group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Standard stenting
Intervention Description
The cilostazol-coated BioMimics 3D stent on the delivery system is deployed into the target lesion.
Primary Outcome Measure Information:
Title
Primary patency of stent at 12 months after the investigational procedure
Description
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.
Time Frame
12 months
Title
Composite of major adverse events (MAEs) up to 12 months after the investigational procedure
Description
MAE is defined as : All death within 30 days after the study procedure. Major amputation of target lower extrimity Clinically driven target lesion revascurarization.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikiko Haraguchi
Phone
+81363617459
Email
OtsukaRegistry-CT@otsuka.jp
Facility Information:
Facility Name
Tokyo Bay Urayasu Ichikawa Medical Center
City
Urayasu City
State/Province
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka City
State/Province
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Kokura Memorial Hospital
City
Kitakyushu City
State/Province
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Shonan Kamakura General Hospital
City
Kamakura City
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Daini Osaka Police Hospital
City
Osaka City, Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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