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Virtual Histology Intravascular Ultrasound to Evaluate Prognostic Risks of Saphenous Vein Graft Disease Before Percutaneous Coronary Intervention.

Virtual Histology Intravascular Ultrasound to Evaluate Prognostic Risks of Saphenous Vein Graft Disease Before Percutaneous Coronary Intervention.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03175952
Enrollment
120
Registered
2017-06-05
Start date
2017-05-01
Completion date
2020-05-01
Last updated
2017-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Adverse Cardiovascular Events, Percutaneous Coronary Intervention, Saphenous Vein Graft Disease, Virtual Histology Intravascular Ultrasound

Brief summary

The study is a prospective cohort study conducted in Tianjin Chest Hospital, China. Patients with saphenous vein graft disease after coronary artery bypass graft, and planning for receiving percutaneous coronary intervention after virtual histology intravascular ultrasound will be enrolled between May 2017 and April 2019. These subjects will be followed up at 1, 6 and 12 months post-operation of PCI to assess the short-term and long-term effect.

Interventions

DIAGNOSTIC_TESTvirtual histology intravascular ultrasound

Patients with saphenous vein graft disease will be examined using virtual histology intravascular ultrasound, and treated with percutaneous coronary intervention. Then they will be followed up at 1, 6 and 12 months.

Sponsors

Tianjin Chest Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients with SVGD after CABG * Planning to receive PCI using drug-eluting stents * 18 to 80 years old * Finishing VH-IVUS examination * Willing to participate in the study and sign informed consent

Exclusion criteria

* Patients with liver disfunction and renal failure * Aspirin and clopidogrel allergy * Acute myocardial infarction after CABG * History of stroke in the past 3 months * Gastrointestinal bleeding and hemoptysis recently * Vasculitis and non-atherosclerotic coronary artery disease * Coagulation disorders * History of malignancy * Women during pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Incidence of major adverse cardiovascular eventsafter PCI for saphenous vein graft disease (SVGD) in one yearCardiac death, myocardial infarction, target lesion revascularization and target vessel revascularization are all major adverse cardiovascular events

Secondary

MeasureTime frameDescription
Thrombolysis In Myocardial Infarction (TIMI) flow in 24 hours after PCI for the SVGD24 hours after PCI for the SVGD
Number of slow reflow, no reflow or distal embolization of the saphenous vein graft after PCI on the basis of Corrected TIMI Frame Count (TFC)24 hours after PCI for the SVGD
Success rate of PCI24 hours after PCI for the SVGDThe residual stenosis of SVG is less than 50% and achieving TIMI flow 3

Countries

China

Contacts

Primary ContactXiang Li, Ph.D.
lixiang_pucri@bjmu.edu.cn0086-010-82805775-622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026