Status:
UNKNOWN
Sufficient Treatment of Peripheral Intervention by Cilostazol
Lead Sponsor:
Kansai Rosai Hospital
Collaborating Sponsors:
Association for Establishment of Ebvidence in Interventions
Conditions:
Arteriosclerosis Obliterans
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
Recently, Nanto et al. reported that cilostazol effectively prevented restenosis in a retrospective analysis of 121 femoropopliteal artery lesions in percutaneous transluminal angioplasty (PTA) patien...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00912756
Start Date
March 1 2009
End Date
September 1 2012
Last Update
July 22 2010
Active Locations (13)
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1
Shinkoga Hospital
Kurume, Fukuoka, Japan, 8308577
2
Hyogo College of Medicine Hopital
Nishinomiya, Hyōgo, Japan, 663-8501
3
Department of Cardiology, Kanazawa Cardiovascular Hospital
Kanazawa, Ishikawa-ken, Japan, 920-0007
4
Department of Cardiology,Naganoken Koseiren Shinonoi
Nagano, Nagano, Japan, 3888004