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:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT02644434
Eligibility Criteria:
Inclusion Criteria:
\-
Clinical Inclusion Criteria:
1. Subject must be male or nonpregnant female ≥18 years of age and ≤75 years of age;
2. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
3. Subject is eligible for PCI;
4. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed;
5. Subject is willing to comply with all protocol-required follow-up evaluation.
Angiographic Inclusion Criteria:
1. Subjects have coronary bifurcation lesions requiring PCI with stent implantation according to clinical guidelines and/or the operator's judgement;
2. Visually estimated reference vessel diameter (RVD) of target main vessel ≥2.5 mm and ≤4.0 mm;
3. Visually estimated RVD of target side branch ≥ 2.0mm;
4. Coronary anatomy is likely to allow delivery of a study device to the target lesion(s);
5. V-RESOLVE score ≥ 12 points.
Exclusion Criteria:
\-
Clinical Exclusion Criteria:
1. Subject has a known allergy to contrast (that cannot be adequately pre-medicated) and/or the trial stent system or protocol-required concomitant medications (e.g., stent alloy, stainless steel, sirolimus, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin);
2. Planned surgery within 6 months after the index procedure;
3. Subject has one of the following (as assessed prior to the index procedure):
* Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 12 months；
* Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.);
* Planned procedure that may cause non-compliance with the protocol or confound data interpretation;
4. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions;
5. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint;
6. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure;
7. Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure);
8. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential);
9. Subject with left ventricular ejection fraction \< 35%;
10. Subject has preoperative renal dysfunction: serum creatinine\>2.0mg/dl (176.82umol/L).
Angiographic Exclusion Criteria:
1. Left main lesions;
2. In case of acute myocardial infarction of which the culprit vessel located at the left anterior descending (LAD) artery, the bifurcation lesion (LAD/diagonal branch \[RVD\>2.5mm\]) which is proximal to occluded LAD segment should be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02644434
Study Brief:
Protocol Section:
NCT02644434