ischemic heart disease
Conditions
Interventions
Implantation of TRE-956
Implantation of Cypher
Sponsors
Terumo corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is eligible for PCI or CABG. The target lesion is a single de novo coronary artery lesion one or 2 vessels. The target lesion length must be <= 30 mm (visual estimate). The target reference vessel diameter must be >= 2.5mm and <= 3.5mm (visual estimate).
Exclusion criteria
Exclusion criteria: Evidence of an acute myocardial infarction within 72 hours of the intended treatment. Stroke or transient ischemic attack within the prior 90 days. Active peptic ulcer or upper GI bleeding within the prior 180days. Documented LVEF <30%. Patient has received a immunosuppressant. Planned surgery with antiplatelet drug withdrawal after index procedure. Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment. Previous DES ( less than 1 year) anywhere within the target vessel . Significant (>50%) stenosis proximal or distal to the target lesion . Ostial or bifurcation target lesion Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated. Target lesion is located or supplied by an arterial or venous bypass graft. Target lesion involves a side branch >2.0mm in diameter. The target lesion requires treatment with a device other than PTCA prior to stent placement . Unprotected Left main coronary artery disease (stenosis >50%).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TVF at 9M | — |
Countries
Japan
Outcome results
None listed