Baseline V-RESOLVE Score Guided Versus Angiography Guided Stent Implantation in Coronary Bifurcation Lesions (CIT-RESOLVE II)

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous Coronary Intervention, Coronary Bifurcation Intervention Read More

Inclusion Criteria:

1. 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.

2. 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);

Exclusion Criteria:

1. 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).

2. 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.