Active, not recruitingNo phase
Evaluate the Efficacy and Safety of the Cilostazol-coated BioMimics 3D Stent System in Patients with Peripheral Arterial Occlusive Disease
Key facts
- Who runs it
- Otsuka Medical Devices Co., Ltd. Japan
- Where
- Japan5 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 24 people, planned
- Started
- 10 Mar 2023
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Treatments tested
- Standard stenting
- Record updated
- 7 February 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 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
- Patient who administered orally cilostazol within 7 days prior to the study procedure
- Patients with a history of major amputation of the target lower extremity
- Patients with coagulopathy
- Patients with renal insufficiencyor on dialysis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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
The group in the trial
- CLZ-BM3D groupTreatment being tested
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.
Treatment: Standard stenting
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 7 February 2025