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Sufficient Treatment of Peripheral Intervention by Cilostazol

Information source: Kansai Rosai Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arteriosclerosis Obliterans

Intervention: cilostazol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Kansai Rosai Hospital

Official(s) and/or principal investigator(s):
Osamu Iida, Study Director, Affiliation: Kansai Rosai Hospital

Overall contact:
Osamu Iida, Phone: +81-6-6416-1221

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) 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.

Clinical Details

Official title: Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Angiographic restenosis rate

Secondary outcome: Cardiovascular events

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Osamu Iida, Phone: +81-6-6416-1221

Kansai Rosai Hospital and seven others, Amagasaki, Japan; Recruiting
Osamu Iida, Principal Investigator

Kishiwada Tokushukai Hospital, Kishiwada, Japan; Recruiting
Yoshiaki Yokoi, Phone: 81-72-445-9915

Kokura Memorial Hospital, Kitakyusy, Japan; Recruiting
Hiroyoshi Yokoi, Phone: 81-93-921-2231

Shinshu University Hospital, Matsumoto, Japan; Recruiting
Yusuke Miyashita, Phone: 81- 263-35-4600

Caress Sapporo Tokeidai Memorial Hospital, Sapporo, Japan; Recruiting
Kazushi Urasawa, Phone: 81-11-251-1221

Sendai Kousei Hospital, Sendai, Japan; Recruiting
Naoto Inoue, Phone: 81-22-222-6181

Kikuna Memorial Hospital, Yokohama, Japan; Recruiting
Akira Miyamoto, Phone: 81-45-402-7111

Saiseikai Yokohama- City Eastern Hospital, Yokohama, Japan; Recruiting
Keisuke Hirano, Phone: 81-45-576-3000

Shinkoga Hospital, Kurume city, Fukuoka 8308577, Japan; Not yet recruiting
Shintani Yoshiaki, Phone: 81-942-38-2222

Hyogo College of Medicine Hopital, Nishinomiya city, Hyogo 663-8501, Japan; Not yet recruiting
Daizo Kawasaki, Phone: 0798-45-6111

Department of Cardiology, Kanazawa Cardiovascular Hospital, Kanazawa city, Ishikawa 920-0007, Japan; Not yet recruiting
Taketsugu Tsuchiya, Phone: 81-76-253-8000

Department of Cardiology,Naganoken Koseiren Shinonoi, Nagano-city, Nagano 3888004, Japan; Recruiting
Norihiko Shinozaki, Phone: 81-26-292-2261

Omihachiman Community Medical Center, Omihachiman city, Shiga 523-0082, Japan; Not yet recruiting
Kan Zen, Phone: 81-748-33-3151

Additional Information

Starting date: March 2009
Last updated: July 21, 2010

Page last updated: August 23, 2015

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