JPRN-jRCT2072220114
Recruiting
未知
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 Protocol Number: EVT-22-001)
akamura Masato0 sites24 target enrollmentMarch 14, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Patients with peripheral occlusive arterial disease
- Sponsor
- akamura Masato
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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 \=\<50mm 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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 1
Clinical Trial for Prevention of Cisplatin-Induced Renal NephrotoxicityCancerJPRN-jRCTs041220021Kondo Masashi21
Active, not recruiting
Phase 1
Reseach study that will evaluate the efficacy and safety of Bilastine in reducing itching in patients with chronic spontaneous urticaria and other skin diseases.Chronic spontaneous urticaria and the following skin disorders:1 - Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, autosensitisation dermatitis, dyshidrotic eczema, asteatotic eczema, lichen simplex chronicus).2 - Prurigo (acute prurigo, subacute prurigo, chronic prurigo).3 - Cutaneous pruritus (systemic cutaneous pruritus, local cutaneous pruritus).MedDRA version: 19.0Level: HLTClassification code 10012435Term: Dermatitis and eczemaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 19.0Level: PTClassification code 10037083Term: PrurigoSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 19.0Level: PTClassification code 10052568Term: Urticaria chronicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2016-001505-17-ESFAES FARMA, S.A.115
Active, not recruiting
Phase 1
Reseach study that will evaluate the efficacy and safety of Bilastine in reducing itching in patients with chronic spontaneous urticaria and other skin diseases.EUCTR2016-001505-17-HUFAES FARMA, S.A.115
Recruiting
Phase 2
Exploratory study to investigate the efficacy of a novel mucosal protection method for oral mucositisOral mucositisMucous membrane disorderK123JPRN-jRCTs062220084Omori Kazuhiro30
Recruiting
Phase 2
A Expoloratory Study to evaluate the Efficacy and Safety of Hydrocortisone for the Prevention of Symptomatic Vasospasm after Subarachnoid Hemorrhage.Patients with subarachnoid hemorrhage due to cerebral aneurysm rupturesubarachnoid hemorrhage, symptomatic vasospasm, hydrocortisoneJPRN-jRCTs051230153ozumi Yoichi100