NCT02219594

The Comparative Study of OCT，Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Xuzhou Central Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In-stent restenosis is a major reason of coronary heart disease recurrence .Even in drug eluting stent(DES), Restenosis rate could be up to 10% in diabetes and complex lesions though it was about 3-5% in general. It is particularly important that in-stent restenosis after implantation was early diagnosed and detected. The evaluation of OCT imaging is more accurate for narrow area calculation, more clear for narrow organization structure and more specific for detecting tissue types.It is currently the best way for restenosis histologic diagnosis.But it has many weakness such as the higher cost,an invasive test, expensive instrument, relatively complicated to operate,and etc.In this study, OCT image was regard as the "gold standard" of stent restenosis. The improvement of spatial resolution of Gemstone CT can effectively improve the imaging quality and the measurement's accuracy of coronary artery stents.The diagnostic value of in-stent restenosis of Gemstone CT is higher than of the 320-detector row spiral CT. To a certain extent, the gemstone CT can replace OCT for examining the in-stent restenosis. This study will examine the degree of in-stent restenosis by the gemstone CT and the 320-detector row spiral CT and compare the two ways on the basis of the result of OCT.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DEVICE	CT image for patient with suspected in-stent restenosis	Gemstone CT or 320-detector row spiral CT was assigned randomly to patient who was suspected in-stent restenosis.About after 10 days,they would accept the check of OCT which wold be the "gold standard" of in-stent restenosis.

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-08-19
• Last updated: 2014-08-19

Locations

1 site across 1 country: China