Peripheral Arterial Disease
Conditions
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
Interventions
DEVICEStandard stenting
The cilostazol-coated BioMimics 3D stent on the delivery system is deployed into the target lesion.
Sponsors
Otsuka Medical Devices Co., Ltd. Japan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency of stent at 12 months after the investigational procedure | 12 months | 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 | 12 months | MAE is defined as : * All death within 30 days after the study procedure. * Major amputation of target lower extrimity * Clinically driven target lesion revascurarization. |
Countries
Japan
Outcome results
None listed