Coronary Artery Disease
Conditions
Keywords
Percutaneous Coronary Intervention, Coronary Bifurcation Intervention
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.
Interventions
PROCEDUREBaseline V-RESOLVE score-guided PCI
Jailed wire technique (JWT): Both main vessel (MV) and side branch (SB) are wired. The MV is stented with wire protection in SB. If suboptimal results exist, the SB would be rewired and a kissing balloon inflation (KBI) is undertaken. Jailed balloon technique: A monorail balloon is advanced into the SB. If there is TIMI flow grade decrease in the SB after MV stenting, the SB balloon is inflated to simulate attempt to reopen the SB. Provisional two-stent strategy: Lesion preparation and MV stenting are consistent with JWT. Provisional SB stenting could be undertaken when suboptimal results occur after SB rewiring and a KBI is undertaken. Elective two-stent strategy: Patients in this subgroup would undergo crush procedure or any other elective two-stent strategy which usually stenting SB before MV stenting.
PROCEDUREAngiography-guided PCI
The choice of interventional strategy was left to the discretion of experienced interventionists based on the coronary angiogram.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| side branch occlusion after main vessel stenting | Immediately after the main vessel | The primary endpoint is side branch occlusion, which is defined as any decrease in TIMI flow grade or absence of flow in side branch after main vessel stent well opposed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The elevation of biomarkers of periprocedural myocardial injury [Creatine Kinase-Myocardial Band (CK-MB) and Troponin I]. | 48h after Percutaneous Coronary Intervention (PCI) | Periprocedural Myocardial Infarction (MI) is defined by the Society for Cardiovascular Angiography and Interventions criteria. |
| Major adverse cardiac events (MACE) | 12-month follow-up | Including all cause death, all myocardial infarction (MI) and target vessel revascularization |
Countries
China
Outcome results
None listed