Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT00552656
Eligibility Criteria:
Inclusion Criteria:
* the patients who have the indication for coronary interventional therapy
* stable angina pectoris (CCS class I II III IV)or unstable angina pectoris (Braunwald class B＆C，I-II) or documented asymptomatic myocardial ischemia
* reference vessel diameter is of 2.5mm to 4.0mm (estimated by investigator)
* significant(\>70%) stenosis of target lesion (estimated by investigator)
* angiographic criteria is complex coronary lesions which includes the followings: multivessel lesions(\>or=two vessels), diffuse long lesions with length\>or=30mm or need two stents overlapped, small vessel lesions(reference vessel diameter\<or=2.5mm estimated by investigator), bifurcation lesions need one or two stents and side branch diameter\>2.0mm, chronic total occlusion lesions(\>3 months), ostial target lesions(including ostial of right coronary artery,left anterior descending artery and left circumflex artery), severe calcification or angulation(location of target lesion at a \>45°bend), protected and unprotected left main lesions, restenosis after bare metal stent implantation(core laboratory decision )
* the patients would like to accept the follow-up and sign the informed consent
Exclusion Criteria:
* pregnant or nursing women
* acute myocardial infarction within the preceding one month
* graft lesions after CABG
* implanted other drug-eluting stents at the same time except the designated one
* left ventricle dysfunction with ejection fraction\<30%(evaluated by echocardiogram with Simpson's double-chamber method)
* renal dysfunction with serum creatinine level\>or=2mg/dl(177umol/L)
* pre-intervention with intravascular brachytherapy or other non-PTCA techniques
* contradictions or allergy to aspirin, heparin, clopidogrel,stainless steel and hypersensitive to contrast media
* anticipated life span \< 12 months
* enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00552656
Study Brief:
Protocol Section:
NCT00552656