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

NCT ID: NCT05503407

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2023-04-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Baseline V-RESOLVE score-guided PCI

Lesions with baseline V-RESOLVE <14 scores would undergo either jailed wire technique or provisional two-stent strategy;

Lesions with baseline V-RESOLVE ≥14 scores would undergo either jailed balloon technique or elective two-stent strategy.

Group Type: EXPERIMENTAL

Baseline V-RESOLVE score-guided PCI

Intervention Type: PROCEDURE

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.

Angiography-guided PCI

The choice of interventional strategy was left to the discretion of experienced interventionists based on the coronary angiogram.

Group Type: PLACEBO_COMPARATOR

Angiography-guided PCI

Intervention Type: PROCEDURE

The choice of interventional strategy was left to the discretion of experienced interventionists based on the coronary angiogram.

Interventions

Baseline 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.

Intervention Type: PROCEDURE

Angiography-guided PCI

The choice of interventional strategy was left to the discretion of experienced interventionists based on the coronary angiogram.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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. 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).

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kefei Dou, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kefei Dou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital and National Center for Cardiovascular Diseases

Locations

Fuwai Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2020-1361

Identifier Type: -

Identifier Source: org_study_id