Trial | NCT00912756  Report issue

Title

Sufficient Treatment of Peripheral Intervention by Cilostazol
Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    cilostazol ...

  • Study Participants

    200
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.
Study Started
Mar 31
2009
Primary Completion
Jun 30
2012
Anticipated
Study Completion
Sep 30
2012
Anticipated
Last Update
Jul 22
2010
Estimate

Drug cilostazol

200 mg/day BID

1cilostazol Experimental

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.

2aspirin Active Comparator

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.

Criteria 

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
No Results Posted