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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT01909869
Eligibility Criteria:
Inclusion Criteria:
1. 18yrs≤Age≤75yrs .
2. De novo lesion at native coronary artery.
3. Single target vessel and single target lesion.
4. Lesion length ≤32mm.
5. RVD 2.5mm～4.0mm.
6. DS%≥70% by visual estimation.
7. Target lesion could be covered by only one stent.
8. Subjects are willing to follow the specified requirements follow-up.
9. A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
Exclusion Criteria:
1. AMI within one week.
2. CTO(TIMI0),LM lesion,ostial lesion,graft vessel lesion,bifurcation (side branch RVD≥2.5mm),ISR,mutivessel disease need to be treated.
3. Severe calcified lesion unable to predilate.
4. extremely tortuous proximal to the lesion that is inadequate to stent delivery.
5. NYHA≥Ⅲ or LVEF≤40%.
6. Prior stenting within 1 year.
7. Pregnancy or lactation, and plan in postoperative pregnancy or lactation.
8. Subjects had bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue DAPT healers at least 1 year.
9. There are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (\< 1 year).
10. To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
11. Serious liver and kidney function is not complete person.
12. The investigators think that do not fit to enroll the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01909869
Study Brief:
Protocol Section:
NCT01909869