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

NCT06045039 | Recruiting

• 1 other identifier: HenanICE2023
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia

Keywords

Angioplasty; Coronary Angiography; surgery; Coronary Vessels; diagnostic imaging; pathology; Drug-Eluting Stents; Treatment Outcome

Outcome Measures

Primary Outcomes (3)

• Target lesion failure rate

  cardiac death

  3-12 months

• Target lesion failure rate

  target vessel myocardial infarction (TVMI)

  6-12 months

• Target lesion failure rate

  clinically driven target lesion revascularization (TLR)

  6-12 months

Secondary Outcomes (1)

• minimum lumen area and lumen stenosis rate

  6-12months

Study Arms (1)

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

Interventions

Stent-balloon-stent (SBS) technique OTHER

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.

Stent-balloon-stent (SBS) technique

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Xianpei Wang, MD

  FF

  STUDY CHAIR

Central Study Contacts

Jin Gao, BD

CONTACT

+86 371 58681130; gao-jin@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)