coronary heart disease
Conditions
Interventions
Tivoli:Stenting
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-79 yrs, male or non-pregnant female; (2) Patients with asymptomatic ischemia, stable or unstable angina; (3) Patient understands the study aims and provides written Informed Consent; (4) Willing to comply with all specified follow-up evaluations more than 1 year. Angiographic Inclusion Criteria: (5) Target lesion is de novo and target lesion stenosis >=70% (visual estimate); (6) Target lesion RVD>=2.25mm and<=4.5 mm, the length of the target lesion <50mm; (7) Target lesion number <= 2 per person: a) For only 1 target lesion, special size Tivoli stent shoud be used; b) For 2 target lesions, special size Tivoli stent could be used in only one lesion; for the other lesion, only normal size stent could be used; (8) No more than 2 stents for one target lesion. Only 1 or 2 special size Tivoli stents can be used in the lesion which involved in special size Tivoli stent; (9) Acceptable candidate for coronary artery bypass grafting (CABG).
Exclusion criteria
Exclusion criteria: (1) Renal dysfunction, renal failure (Scr>=2.0mg/dl, 177umol/L) or dialysis patient; (2) AMI within 1 week prior to the index procedure and CK-MB is not reach normal level; (3) Received coronary stent within the past 6 months or the target vessel has received stent; (4) Serious heart failure (NYHA > III) or left ventricular ejection fraction (LVEF) of =3; (9) Life expectancy shorter than 12 months; (10) Participated in another investigational drug or device study in the past 30 days; (11) Bad compliance with follow-up requirements could be predicted. Angiographic Exclusion Criteria: (12) Totally occluded lesion (TIMI flow = 0); (13) Target lesion is severely calcified; (14) Target lesion is in left main coronary artery; (15) Target lesion is ostial in location (within 3.0 mm of aorta, LAD or LCX origin); (16) Target lesion is in arterial graft; (17) Side branch of the target lesion included ostial narrowing >=50% DS and was >=2.0 mm diameter; (18) In-stent restenosis lesion; (19) Untreated thrombus in target vessel; (20) Target lesion was located in severely angulated(>=90 degree) or excessive tortuous vessel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late Loss;MACE; | — |
Countries
China
Contacts
Public ContactQuan Fang
Outcome results
None listed