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The effect of Baseline V-RESOLVE score to guide coronary high-risk bifurcation intervention treatment for reducing side branch occlusion and perioperative myocardial infarction

Multicenter, prospective, randomized controlled study to evaluate the effect of baseline V-RESOLVE score guiding coronary high-risk bifurcation intervention treatment for reducing side branch occlusion and perioperative myocardial infarction

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046842
Enrollment
Unknown
Registered
2021-05-29
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary heart disease

Interventions

experiment group:Decide on branch protection strategy based on the result of Baseline V-RESOLVE score
control group:Decide on branch protection strategy based on the experience of PCI operater

Sponsors

Hunan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Clinical standards: (1) Males or non-pregnant females aged 18 -7 5 years old; (2) The patient is definitely diagnosed with coronary heart disease; (3) The patient has manifestations of angina pectoris, acute coronary syndrome, etc., and requires percutaneous coronary intervention; (4) The patient (or legal guardian) is fully informed about the trial process and signs an informed consent form; (5) The patient can accept the follow-up process after the trial. 2. Coronary angiography standards: (1) The patient's coronary heart disease involves important coronary bifurcation vessels (visual diameter >= 2.0mm), and stent placement is required; (2) The anatomical characteristics of the coronary artery allow the stent to be delivered to the target lesion.

Exclusion criteria

Exclusion criteria: 1. Clinical exclusion criteria: (1) The patient is allergic to related devices used in PCI (stent alloys, drug coatings, etc.); (2) The patient plans to undergo other operations within 6 months after PCI; (3) The patient has the following conditions: 1) Serious diseases (malignant tumors, heart failure, etc.), and the life expectancy is less than 12 months; 2) Alcohol dependence, caffeine dependence, drug addiction, etc.; 3) There are other surgery/treatment plans that may affect the compliance with this trial; (4) The patient has coagulation dysfunction; (5) The patient is participating in other clinical trials and has not yet reached the research endpoint; (6) The patient plans to participate in other drugs/device clinical trials in the next 12 months; (7) Female patients plan to pregnant/birth within the next 12 months; (8) Patient's ejection fraction 2.0mg/dl (176.82umol/L).

Design outcomes

Primary

MeasureTime frame
Branch vessel occlusion or TIMI blood flow decreased after PCI;Perioperative myocardial infarction;

Secondary

MeasureTime frame
The incidence of major adverse cardiovascular events;

Countries

China

Contacts

Public ContactPan Hongwei

Hunan Provincial People's Hospital

pan.hw@foxmail.com+86 13487311869

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026