Clinical trial NCT05759819: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Otsuka Medical Devices Co., Ltd. Japan
Sponsor class: INDUSTRY
First posted: 2023-03-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Primary patency of stent at 12 months after the investigational procedure
timeFrame: 12 months
measure: Composite of major adverse events (MAEs) up to 12 months after the investigational procedure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Urayasu City
country: Japan
facility: Tokyo Bay Urayasu Ichikawa Medical Center
state: Chiba
city: Fukuoka City
country: Japan
facility: Saiseikai Fukuoka General Hospital
state: Fukuoka
city: Kitakyushu City
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Kamakura City
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Osaka City, Osaka
country: Japan
facility: Osaka Keisatsu Hospital
Study officials:
References: