Sufficient Treatment of Peripheral Intervention by Cilostazol

Study Overview
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Brief Summary
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Recently, Nanto et al. reported that cilostazol effectively prevented restenosis in a retrospective analysis of 121 femoropopliteal artery lesions in percutaneous transluminal angioplasty (PTA) patients who had undergone PTA. In a prospective 3-year follow-up study in 127 patients with similar diseases, the patency rate was significantly higher in the cilostazol group than in the ticlopidine group. It was also found that cilostazol markedly inhibited restenosis during the first 1-year period following endovascular therapy when restenosis is most frequently observed. In addition, there have been sporadic reports that cilostazol was effective in preventing post-stenting restenosis in the coronary artery area. Based on these results, this multicenter study is going to be conducted to prospectively evaluate the usefulness of cilostazol in lower limb endovascular therapy.

Official Title
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Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment

Conditions
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Arteriosclerosis Obliterans

Intervention / Treatment
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* Drug: cilostazol


Participation Criteria
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Eligibility Criteria
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Patient criteria: Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area* Patients who can be monitored for at least 2 years after surgery Lesion criteria: Angiographically-confirmed new significant superficial femoral artery stenosis or occlusive lesions that are 30 cm long or less if stented At least 1 arterial runoff below the knee; stenosis lesions not limiting flow may be included. Occlusive lesions may be included. Exclusion criteria: Patients with or at risk of hemorrhagic complications or patients with bleeding tendency Patients with congestive cardiac failure Patients with a drug-eluting stent Patients with acute lower limb ischemia Patients with creatinine of 2 mg/dL or more(without dialysis) patients with a history of serious adverse reaction such as leukopenia, hepatic dysfunction, or renal dysfunction, or hypersensitivity to any component of the study drug. Lesion criteria: Remnant inflow Severe calcification No arterial runoff below the knee

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1cilostazol<br>Cilostazol group: Treatment with cilostazol 200 mg/day BID (morning and evening) and aspirin at 100 mg/day will be started 3 to 7 days prior to EVT and continued until the end of the 2-year follow-up period. | Drug: cilostazol<br>* 200 mg/day BID<br>|
| Active Comparator: 2aspirin<br>Non-cilostazol group: Treatment with aspirin 100 mg/day will be started 3 to 7 days prior to EVT and continued until the end of the 2-year follow-up period. | Drug: cilostazol<br>* 200 mg/day BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic restenosis rate |  | 12 months +- 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endovascular therapy, restenosis, cilostazol, femoropopliteal artery lesions, Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area