Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions

February 26, 2024 updated by: Xianpei Wang, Henan Institute of Cardiovascular Epidemiology
The treatment of coronary bifurcation lesions continue to remain challenges. Due to the special hemodynamics caused by the special anatomical structure of the coronary bifurcation, it is easy to cause vascular crest displacement and plaque formation. The existing single-stent strategy and double-stent strategy are easy to cause vascular crest offset, stent accumulation, in-stent thrombosis, in-stent restenosis and other poor long-term prognosis. Stent-balloon-stent (Stent-balloon-stent, SBS) technique enables the guide wire to enter the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm².The SBS technique reduces the risk of branch vascular dissection, occlusion, snow shoveling phenomenon, maintain the original state of bifurcated blood vessels to the greatest extent, should have a good impact on the long-term prognosis of patients with coronary bifurcation lesions (CBL). The purpose of this study is to explore the feasibility, safety and effectiveness of SBS technique.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a study to evaluate the application of stent-balloon-stent (Stent-balloon-stent, SBS) in complex bifurcation lesions. 1-2mm from the side branch (SB) opening, the stent was implanted in the side branch, and then the stent was implanted in the main vessel (MV).The guide wire enters the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm².The patients were examined by coronary angiography before operation and 6-12 months after operation, and the related data such as stenosis rate and minimum lumen diameter of diseased vessels were recorded. The incidence of target vessel failure (TLF) 6-12 months later, including cardiogenic death, target vessel myocardial infarction and clinically driven target vessel revascularization, was taken as the main clinical end point. The corresponding data of the patients before and after operation were obtained, and the clinical efficacy was compared with the existing double stent strategy.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Fuwai Central China Cardiovascular Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who had evidence of myocardial ischemia and received interventional therapy for coronary bifurcation lesions in our center from January 2023 to December 2023.

Description

Inclusion Criteria:

  • There is evidence of myocardial ischemia, such as coronary angiography, including patients with stable angina pectoris, unstable angina pectoris, asymptomatic myocardial ischemia and acute myocardial infarction (> 24 hours).
  • All bifurcation lesions were Medina 1, 1, 1 or 0, 1, 1 with reference vessel diameter (RVD) in the SB ≥2.5 mm by visual estimation and had to meet DEFINITION criteria of complex bifurcations
  • Patients who can tolerate long-term antiplatelet therapy
  • None of the vessels related to bifurcation lesions have received stent surgery
  • Patients who agree and sign an informed consent form

Exclusion Criteria:

  • Patients who are unwilling to sign the relevant informed consent form
  • Patients with severe surgical contraindications
  • Life expectancy of patients is less than 12 months
  • Patients who have previously undergone stent implantation or surgical coronary artery bypass grafting for related lesions
  • Patients with severe hepatorenal insufficiency
  • Heart failure patients with NYHA grade ≥ Ⅲ
  • Patients who are scheduled for surgery requiring antiplatelet medication interruption within 6 months
  • Patients who need chronic oral anticoagulation
  • Any clinical condition of the patient may interfere with medication compliance or long-term follow-up
  • Pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stent-balloon-stent (SBS) technique
Patients with coronary bifurcation lesions underwent stent-balloon-stent (SBS) technique. The procedure of this technique is to implant the stent into the side branch at the 1~2mm, which is away from the opening of the branch, and then implant the stent into the main vessel. The guide wire enters the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm².
Other: Stent-balloon-stent (SBS) technique
Patients with coronary bifurcation lesions underwent stent-balloon-stent (SBS) technique. The procedure of this technique is to implant the stent into the side branch at the 1~2mm, which is away from the opening of the branch, and then implant the stent into the main vessel. The guide wire enters the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm².

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion failure rate
Time Frame: 3-12 months
cardiac death
3-12 months
Target lesion failure rate
Time Frame: 6-12 months
target vessel myocardial infarction (TVMI)
6-12 months
Target lesion failure rate
Time Frame: 6-12 months
clinically driven target lesion revascularization (TLR)
6-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
minimum lumen area and lumen stenosis rate
Time Frame: 6-12months
minimum lumen area and lumen stenosis rate
6-12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Institute of Cardiovascular Epidemiology

Investigators

  • Study Chair: Xianpei Wang, MD, FF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanICE2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Others can obtain the individual participant data from the researcher by reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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