Ischemic heart disease
Conditions
Interventions
paclitaxel-eluting balloon
conventional balloon angioplasty
Sponsors
Nipro Corporation (Osaka, Japan)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria were ISR in bare-metal stent or drug-eluting stent (sirolimus-eluting, zotarolimus-eluting or everolimus-eluting stent), reference vessel diameter of 2.0–4.0 mm, and lesion length of less than 22 mm.
Exclusion criteria
Exclusion criteria: The lesion containing proximal or distal tortuosity with more than 90-degree angle; multiple lesions in the target vessel; total coronary artery occlusion; heavily calcified lesion; lesion in bypass graft; or bifurcation lesion with side branch of larger than 2.0 mm in diameter was not regarded as the target lesion. Clinical exclusion criteria were as follows: left ventricular ejection fraction of less than 30%; myocardial infarction within 72 hr before enrollment; intolerance to antiplatelet or anticoagulant drugs, drugs similar to paclitaxel and contrast media; acute or chronic renal dysfunction with serum creatinine level of not less than 1.5 mg/dL; patients with severe concomitant systemic illness whom the treating physician considered it better to exclude; any coronary intervention procedure within previous 28 days; patients with cerebral infarction, transient cerebral ischemic attack or hemorrhagic gastric ulcer within previous 6 months; women who were pregnant or of childbearing potential; patients with implantation of DES within previous 6months; and patients with left main disease (LMT>50% diameter stenosis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| target vessel failure (TVF) at 6-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| lesion success (attainment of less than 50% in-stent residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis), and procedure success (attainment of a final lesion success and no in-hospital major adverse cardiac events). Secondary angiographic endpoints were in-stent binary restenosis rate and late lumen loss. Secondary clinical endpoints included target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis, myocardial infarction, death, and major adverse cardiac events. | — |
Countries
Japan
Contacts
Public ContactSeiji Habara
Kurashiki Central Hospital Department of Cardiology
Outcome results
None listed