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

• Conditions: Major Adverse Cardiovascular Events; Saphenous Vein Graft Disease; Percutaneous Coronary Intervention; Virtual Histology Intravascular Ultrasound
• Interventions: Diagnostic Test: virtual histology intravascular ultrasound

• Registration Number: NCT03175952
• Lead Sponsor: Tianjin Chest Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13
• Primary Completion: 2019-04-30
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCI	virtual histology intravascular ultrasound	-

Primary Outcome Measures

Name	Time	Method
Incidence of major adverse cardiovascular events	after PCI for saphenous vein graft disease (SVGD) in one year	Cardiac death, myocardial infarction, target lesion revascularization and target vessel revascularization are all major adverse cardiovascular events

Secondary Outcome Measures

Name	Time	Method
Success rate of PCI	24 hours after PCI for the SVGD	The residual stenosis of SVG is less than 50% and achieving TIMI flow 3
Thrombolysis In Myocardial Infarction (TIMI) flow in 24 hours after PCI for the SVGD	24 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

Trial Locations

Locations (1)

Tianjin Chest Hospital; 🇨🇳 Tianjin, Tianjin, China