Clinical trial NCT05503407: Baseline V-RESOLVE Score Guided Versus Angiography Guided Stent Implantation in Coronary Bifurcation Lesions (CIT-RESOLVE II)
Official title: Baseline V-RESOLVE Score Guided Versus Angiography Guided Stent Implantation in Coronary Bifurcation Lesions (CIT-RESOLVE II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Coronary Bifurcation Intervention
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-08-16
Enrollment: 1104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether baseline V-RESOLVE score guided intervention is associated with significant reduction of side branch occlusion rates compared to angiography guided intervention in patients with coronary bifurcation lesions.

Detailed description: A number of 1104 patients scheduled for elective percutaneous coronary intervention (PCI) with native coronary bifurcation lesions suitable for stent implantation are included in the present study. This study will be conducted in two stages with 552 patients each. In the first stage, all patients receive angiography-guided PCI. In the second stage, all patients receive PCI under the guidance of baseline V-RESOLVE score.

Eligibility criteria: 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.

Primary outcomes:
measure: side branch occlusion after main vessel stenting
timeFrame: Immediately after the main vessel
Secondary outcomes:
measure: The elevation of biomarkers of periprocedural myocardial injury [Creatine Kinase-Myocardial Band (CK-MB) and Troponin I].
timeFrame: 48h after Percutaneous Coronary Intervention (PCI)
measure: Major adverse cardiac events (MACE)
timeFrame: 12-month follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Fuwai Hospital and National Center for Cardiovascular Diseases
name: Kefei Dou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: