Sufficient Treatment of Peripheral Intervention by Cilostazol
Information source: Kansai Rosai Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
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
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
Kikuna Memorial Hospital, Yokohama, Japan; Recruiting
Akira Miyamoto, Phone: 81-45-402-7111
Akira Miyamoto, Phone: 81-45-402-7111
Kishiwada Tokushukai Hospital, Kishiwada, Japan; Recruiting
Yoshiaki Yokoi, Phone: 81-72-445-9915
Yoshiaki Yokoi, Phone: 81-72-445-9915
Saiseikai Yokohama- City Eastern Hospital, Yokohama, Japan; Not yet recruiting
Keisuke Hirano, Phone: 81-45-576-3000
Keisuke Hirano, Phone: 81-45-576-3000
Sendai Kousei Hospital, Sendai, Japan; Not yet recruiting
Naoto Inoue, Phone: 81-22-222-6181
Naoto Inoue, Phone: 81-22-222-6181
Kokura Memorial Hospital, Kitakyusy, Japan; Recruiting
Hiroyoshi Yokoi, Phone: 81-93-921-2231
Hiroyoshi Yokoi, Phone: 81-93-921-2231
Shinshu University Hospital, Matsumoto, Japan; Not yet recruiting
Yusuke Miyashita, Phone: 81- 263-35-4600
Yusuke Miyashita, Phone: 81- 263-35-4600
Caress Sapporo Tokeidai Memorial Hospital, Sapporo, Japan; Recruiting
Kazushi Urasawa, Phone: 81-11-251-1221
Kazushi Urasawa, Phone: 81-11-251-1221
Additional Information
Starting date: March 2009
Ending date: September 2012
Last updated: June 19, 2009
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