Arteriosclerosis Obliterans Clinical Trial
— STOP-ICOfficial title:
Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Japan | Kansai Rosai Hospital and seven others | Amagasaki | |
Japan | Department of Cardiology, Kanazawa Cardiovascular Hospital | Kanazawa city | Ishikawa |
Japan | Kishiwada Tokushukai Hospital | Kishiwada | |
Japan | Kokura Memorial Hospital | Kitakyusy | |
Japan | Shinkoga Hospital | Kurume city | Fukuoka |
Japan | Shinshu University Hospital | Matsumoto | |
Japan | Department of Cardiology,Naganoken Koseiren Shinonoi | Nagano-city | Nagano |
Japan | Hyogo College of Medicine Hopital | Nishinomiya city | Hyogo |
Japan | Omihachiman Community Medical Center | Omihachiman city | Shiga |
Japan | Caress Sapporo Tokeidai Memorial Hospital | Sapporo | |
Japan | Sendai Kousei Hospital | Sendai | |
Japan | Kikuna Memorial Hospital | Yokohama | |
Japan | Saiseikai Yokohama- City Eastern Hospital | Yokohama |
Lead Sponsor | Collaborator |
---|---|
Kansai Rosai Hospital | Association for Establishment of Ebvidence in Interventions |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Angiographic restenosis rate | 12 months +- 1 month | No | |
Secondary | Cardiovascular events | Yes |
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