Clinical trial NCT00912756: Sufficient Treatment of Peripheral Intervention by Cilostazol
Official title: Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arteriosclerosis Obliterans
Keywords: endovascular therapy
restenosis
cilostazol
femoropopliteal artery lesions
Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area
Lead sponsor: Kansai Rosai Hospital
Sponsor class: OTHER
Collaborators: name: Association for Establishment of Ebvidence in Interventions
First posted: 2009-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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) 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.


Eligibility 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

Primary outcomes:
measure: Angiographic restenosis rate
timeFrame: 12 months +- 1 month
Secondary outcomes:
measure: Cardiovascular events
Other outcomes:
Locations:
city: Kurume city
country: Japan
facility: Shinkoga Hospital
state: Fukuoka
city: Nishinomiya city
country: Japan
facility: Hyogo College of Medicine Hopital
state: Hyogo
city: Kanazawa city
country: Japan
facility: Department of Cardiology, Kanazawa Cardiovascular Hospital
state: Ishikawa
city: Nagano-city
country: Japan
facility: Department of Cardiology,Naganoken Koseiren Shinonoi
state: Nagano
city: Omihachiman city
country: Japan
facility: Omihachiman Community Medical Center
state: Shiga
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital and seven others
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
city: Kitakyusy
country: Japan
facility: Kokura Memorial Hospital
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
city: Sapporo
country: Japan
facility: Caress Sapporo Tokeidai Memorial Hospital
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
city: Yokohama
country: Japan
facility: Kikuna Memorial Hospital
city: Yokohama
country: Japan
facility: Saiseikai Yokohama- City Eastern Hospital
Study officials:
affiliation: Kansai Rosai Hospital
name: Osamu Iida
role: STUDY_DIRECTOR
References:
citation: Soga Y, Hamasaki T, Edahiro R, Iida O, Inoue N, Suzuki K, Yokoi Y, Kawasaki D, Zen K, Urasawa K, Aodo K; STOP-IC investigators. Sustained Effectiveness of Cilostazol After Endovascular Treatment of Femoropopliteal Lesions: Midterm Follow-up From the Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) Study. J Endovasc Ther. 2018 Jun;25(3):306-312. doi: 10.1177/1526602818771358. Epub 2018 Apr 30.
citation: Iida O, Yokoi H, Soga Y, Inoue N, Suzuki K, Yokoi Y, Kawasaki D, Zen K, Urasawa K, Shintani Y, Miyamoto A, Hirano K, Miyashita Y, Tsuchiya T, Shinozaki N, Nakamura M, Isshiki T, Hamasaki T, Nanto S; STOP-IC investigators. Cilostazol reduces angiographic restenosis after endovascular therapy for femoropopliteal lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol study. Circulation. 2013 Jun 11;127(23):2307-15. doi: 10.1161/CIRCULATIONAHA.112.000711. Epub 2013 May 7.