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

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ClinicalTrials.gov Identifier: NCT06045039
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Xianpei Wang, Henan Institute of Cardiovascular Epidemiology

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Coronary Disease Heart Diseases Cardiovascular Diseases Vascular Diseases Myocardial Ischemia Other: Stent-balloon-stent (SBS) technique

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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Target lesion failure rate [ Time Frame: 3-12 months ]
    cardiac death

  2. Target lesion failure rate [ Time Frame: 6-12 months ]
    target vessel myocardial infarction (TVMI)

  3. Target lesion failure rate [ Time Frame: 6-12 months ]
    clinically driven target lesion revascularization (TLR)


Secondary Outcome Measures :
  1. minimum lumen area and lumen stenosis rate [ Time Frame: 6-12months ]
    minimum lumen area and lumen stenosis rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045039


Contacts
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Contact: Jin Gao, BD +86 371 58681130 gao-jin@foxmail.com

Locations
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China, Henan
Fuwai Central China Cardiovascular Hospital Recruiting
Zhengzhou, Henan, China
Sponsors and Collaborators
Henan Institute of Cardiovascular Epidemiology
Investigators
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Study Chair: Xianpei Wang, MD FF
More Information
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Responsible Party: Xianpei Wang, Chief Physician, Henan Institute of Cardiovascular Epidemiology
ClinicalTrials.gov Identifier: NCT06045039    
Other Study ID Numbers: HenanICE2023
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Others can obtain the individual participant data from the researcher by reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xianpei Wang, Henan Institute of Cardiovascular Epidemiology:
Angioplasty
Coronary Angiography
surgery
Coronary Vessels
 diagnostic imaging
pathology
Drug-Eluting Stents
Treatment Outcome
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Coronary Disease
Myocardial Ischemia