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The trial is taking place at:
T

Tokyo Bay Urayasu Ichikawa Medical Center | Clinical Service Co., Ltd.

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

O

Otsuka Medical Devices

Status

Enrolling

Conditions

Peripheral Arterial Disease

Treatments

Device: Standard stenting

Study type

Interventional

Funder types

Industry

Identifiers

NCT05759819
EVT-22-001

Details and patient eligibility

About

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

Full 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

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

CLZ-BM3D group
Experimental group
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.
Treatment:
Device: Standard stenting

Trial contacts and locations

5

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Central trial contact

Mikiko Haraguchi

Data sourced from clinicaltrials.gov

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