Peripheral Arterial DiseaseNCT05759819
Evaluate the Efficacy and Safety of the Cilostazol-coated BioMimics 3D Stent System in Patients with Peripheral Arterial Occlusive Disease
A study testing Standard stenting in people with Peripheral Arterial Disease, run by Otsuka Medical Devices Co., Ltd. Japan at 5 sites in Japan.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Standard stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesJapan
- Study dates
- 10 Mar 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
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- Patients with coagulopathy.
- Patients with renal insufficiencyor on dialysis.
- Patient who administered orally cilostazol within 7 days prior to the study procedure.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Saiseikai Fukuoka General Hospital
Fukuoka, Fukuoka
Shonan Kamakura General Hospital
Kamakura, Kanagawa
Kokura Memorial Hospital
Kitakyushu, Fukuoka
Osaka Keisatsu Hospital
Osaka City, Osaka
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba
About this study
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
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
Read the 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
- Conditions
- Peripheral Arterial Disease
- Being tested
- Standard stenting
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard stentingDevice
The cilostazol-coated BioMimics 3D stent on the delivery system is deployed into the target lesion.
| Study group | Role | What they receive |
|---|---|---|
| CLZ-BM3D group | Experimental | 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. Receives: Device: Standard stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start10 Mar 2023
- Primary completion5 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Medical Devices Co., Ltd. Japan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759819
- Sponsor's protocol ID
- EVT-22-001
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05759819
- Acronym / sponsor ID
- EVT-22-001
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Otsuka Medical Devices Co., Ltd. JapanIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLZ-BM3D group | Experimental | Device: Standard stentingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard stentingThe cilostazol-coated BioMimics 3D stent on the delivery system is deployed into the target lesion. | Device | CLZ-BM3D group |
Primary outcome
Primary patency of stent at 12 months after the investigational procedure
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard stenting in people with Peripheral Arterial Disease, run by Otsuka Medical Devices Co., Ltd. Japan at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency of stent at 12 months after the investigational procedure (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.