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

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03175952
• Other study ID #: 16YFZCSY00800
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2017
• Last updated: September 12, 2017
• Start date: May 1, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: September 2017
• Source: Tianjin Chest Hospital
• Contact: Xiang Li, Ph.D.
• Phone: 0086-010-82805775-622
• Email: lixiang_pucri[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 1, 2020
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• virtual 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.

Locations

Country	Name	City	State
China	Tianjin Chest Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major adverse cardiovascular events	Cardiac death, myocardial infarction, target lesion revascularization and target vessel revascularization are all major adverse cardiovascular events	after PCI for saphenous vein graft disease (SVGD) in one year
Secondary	Thrombolysis In Myocardial Infarction (TIMI) flow in 24 hours after PCI for the SVGD		24 hours after PCI for the SVGD
Secondary	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
Secondary	Success rate of PCI	The residual stenosis of SVG is less than 50% and achieving TIMI flow 3	24 hours after PCI for the SVGD