Sufficient Treatment of Peripheral Intervention by Cilostazol

Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00912756

Acronym

STOP-IC

Enrollment

200

Registered

2009-06-03

Start date

2009-03-31

Completion date

2012-09-30

Last updated

2010-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriosclerosis Obliterans

Keywords

endovascular therapy, restenosis, cilostazol, femoropopliteal artery lesions, Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area

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.

Interventions

DRUGcilostazol

200 mg/day BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Angiographic restenosis rate	12 months +- 1 month

Secondary

Measure	Time frame
Cardiovascular events	—

Countries

Japan

Contacts

Primary ContactOsamu Iida

+81-6-6416-1221

Backup ContactShinsuke Nanto