Short Term and Long Term Effects of Single Stent and Embedded Balloon Angioplasty in the Treatment of Coronary Bifurcation Lesions

• Conditions: Percutaneous Coronary Intervention

• Registration Number: NCT02691819
• Lead Sponsor: ZhangWenduo

Brief Summary

At the same time in the side branch stent expansion vessels were embedded and balloon dilatation technique in for Medina1.1.1 type, 1.0.1 type or 0.1.1 type lesions of interventional therapy for bifurcation lesions, the PCI preoperative and postoperative 6 h, 24h of all patients were at least three times ECG and assay of creatine kinase isoenzyme (CK-MB) and cardiac troponin T (TNT data analysis); immediately after operation and nine months after surgery, coronary angiography, quantitative coronary angiography, evaluation of each main branch and side branch of the lesion degree of stenosis (determination of bifurcation angle, reference vessel diameter, vessel diameter, minimum) and TIMI flow grade; using 256 slice spiral CT scanner to scan each main branch lesion and evaluation a side branch stenosis (determination of bifurcation angle, reference vessel diameter, vessel diameter, minimum). All patients were followed up for 1 months, 6 months, and 9 months follow-up. Cardiovascular events included total cause of death, cardiac death, total re hospitalization rate, recurrent myocardial infarction or unstable angina.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-01
• Status Verified: 2016-01
• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-24
• Last Update Submitted: 2016-02-24
• Study First Posted: 2016-02-25
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Inclusion criteria: selected patients aged 18-80 years of intervention in patients. Baseline characteristics of the patients with screening and recorded by a case by coronary artery angiography of each coronary bifurcation lesions according to the Medina classification method to classify, only select the 1.1.1 type, type 1.0.1 or 0.1.1 type III lesions, a total of 80, respectively, of the type of bifurcation lesions, the random number method lesions were divided into according to the ratio of 1:3 established traditional surgical PCI group 20 lesions and a new operative method for 60 lesions group and interventional therapy. All patients who were involved in the treatment before treatment (sign) or their family members agreed to and signed informed consent. All patients were pre evaluated for long-term oral aspirin (100 mg/, once daily) and clopidogrel (75 mg/ times a day) for at least 1 years

Exclusion Criteria

Be of aspirin or clopidogrel allergy or intolerance are; the illness history of stroke or visceral hemorrhage within six months; serious liver disease and (or) coagulation abnormality; with antiplatelet treatment contraindications or recently proposed surgical person; valvular heart disease, cardiomyopathy, myocarditis, congenital heart disease, peripheral vascular disease, infection endocarditis; late kidney function not whole, tumor and chronic heart failure seriously affect the short-term prognosis of disease.Patients unable to complete follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE	9 months

Trial Locations

Locations (1)

Zhang Wenduo; 🇨🇳 Beijing, Beijing, China