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

NCT ID: NCT02691819

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31

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.

Conditions

Percutaneous Coronary Intervention

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

single stent and embedded balloon angioplasty

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZhangWenduo

OTHER_GOV

Sponsor Role: lead

Responsible Party

ZhangWenduo

Beijing Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhang Wenduo

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhang Wenduo, PHD

Role: CONTACT

drzhangwenduo@163.com

=8613911616799

Facility Contacts

Zhang Wenduo, PHD

Role: primary

drzhangwenduo@163.com

+8613911616799

References

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Other Identifiers

BeijingHZWD001

Identifier Type: -

Identifier Source: org_study_id