Coronary Artery DiseaseNCT05503407
Baseline V-RESOLVE Score Guided Versus Angiography Guided Stent Implantation in Coronary Bifurcation Lesions (CIT-RESOLVE II)
A study testing Baseline V-RESOLVE score-guided PCI and Angiography-guided PCI in people with Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Baseline V-RESOLVE score-guided PCI and Angiography-guided PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Inclusion Criteria:
- Subject must be male or nonpregnant female ≥18 years of age and ≤75 years of age;
- Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
- Subject is eligible for PCI;
- 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;
- Subject is willing to comply with all protocol-required follow-up evaluation.
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- Angiographic Inclusion Criteria:
- Subjects have coronary bifurcation lesions requiring PCI with stent implantation according to clinical guidelines and/or the operator's judgement;
- Visually estimated reference vessel diameter (RVD) of target main vessel ≥2.5 mm and ≤4.0 mm;
- Visually estimated RVD of target side branch ≥ 2.0mm;
- Coronary anatomy is likely to allow delivery of a study device to the target lesion(s);
Who cannot join
- Clinical Exclusion Criteria:
- 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);
- Planned surgery within 6 months after the index procedure;
- 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.);
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- Planned procedure that may cause non-compliance with the protocol or confound data interpretation;
- Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions;
- Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint;
- Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure;
- 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);
- 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);
- Subject with left ventricular ejection fraction < 35%;
- Subject has preoperative renal dysfunction: serum creatinine>2.0mg/dl (176.82umol/L).
- Angiographic Exclusion Criteria:
- Left main lesions;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Baseline V-RESOLVE score-guided PCI, Angiography-guided PCI
- Keywords
- Percutaneous Coronary Intervention, Coronary Bifurcation Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline V-RESOLVE score-guided PCIProcedure or surgery
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 PCIProcedure or surgery
The choice of interventional strategy was left to the discretion of experienced interventionists based on the coronary angiogram.
| Study group | Role | What they receive |
|---|---|---|
| Baseline V-RESOLVE score-guided PCI | Experimental | 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. Receives: Procedure: Baseline V-RESOLVE score-guided PCI |
| Angiography-guided PCI | Placebo comparator | The choice of interventional strategy was left to the discretion of experienced interventionists based on the coronary angiogram. Receives: Procedure: Angiography-guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
side branch occlusion after main vessel stenting
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.
Measured: Immediately after the main vessel
Secondary outcomes (2)
The elevation of biomarkers of periprocedural myocardial injury [Creatine Kinase-Myocardial Band (CK-MB) and Troponin I].
Periprocedural Myocardial Infarction (MI) is defined by the Society for Cardiovascular Angiography and Interventions criteria.
Measured: 48h after Percutaneous Coronary Intervention (PCI)
Major adverse cardiac events (MACE)
Including all cause death, all myocardial infarction (MI) and target vessel revascularization
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Jan 2017
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,104 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kefei Dou, MD, China National Center for Cardiovascular Diseases
- Investigators
- Kefei Dou, MD, PhD, Principal investigator, Fuwai Hospital and National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503407
- Sponsor's protocol ID
- 2020-1361
- Status last verified
- Jun 2023
- First submitted
- 14 Aug 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline V-RESOLVE Score Guided Versus Angiography Guided Stent Implantation in Coronary Bifurcation Lesions (CIT-RESOLVE II)
- ClinicalTrials.gov ID
- NCT05503407
- Acronym / sponsor ID
- 2020-1361
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Coronary Bifurcation Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,104 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline V-RESOLVE score-guided PCI | Experimental | Procedure: Baseline V-RESOLVE score-guided PCILesions 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. |
| Angiography-guided PCI | Placebo comparator | Procedure: Angiography-guided PCIThe choice of interventional strategy was left to the discretion of experienced interventionists based on the coronary angiogram. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Clinical Inclusion Criteria:
- Angiographic Inclusion Criteria:
Key exclusion criteria (17 listed)
- Clinical Exclusion Criteria:
- Angiographic Exclusion Criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline V-RESOLVE score-guided PCIJailed 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. | Procedure or surgery | Baseline V-RESOLVE score-guided PCI |
| Angiography-guided PCIThe choice of interventional strategy was left to the discretion of experienced interventionists based on the coronary angiogram. | Procedure or surgery | Angiography-guided PCI |
Primary outcome
side branch occlusion after main vessel stenting
Time frame: 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.
2 secondary outcomes
The elevation of biomarkers of periprocedural myocardial injury [Creatine Kinase-Myocardial Band (CK-MB) and Troponin I].
Time frame: 48h after Percutaneous Coronary Intervention (PCI)
Major adverse cardiac events (MACE)
Time frame: 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kefei Dou, MD, PhD principal investigator
Fuwai Hospital and National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline V-RESOLVE score-guided PCI and Angiography-guided PCI in people with Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
side branch occlusion after main vessel stenting (time frame: Immediately after the main vessel). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.