Serial EValuation of multiplE Coronary Artery Diseases by an Optical Coherence Tomography; Assessment of the Changes of de Novo Lesions and Comparisons of Neointimal Coverage Between Xience Prime® Versus Cypher SelectTM Stents; SEVEN-Xience Study

Phase 4

Completed

• Conditions: Multi-vessel Diseases, Angina
• Interventions: Drug: Pravastatin 20mg; Device: Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA); Device: Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL); Drug: Atorvastatin 40mg

• Registration Number: NCT01856374
• Lead Sponsor: Yonsei University

Brief Summary

This study is a prospective open-labeled, randomized study to compare the neointimal coverage at 3 months and 12 months and its serial changes between 3 months and 12 months according to the implanted DES and evaluate the serial changes in the proximal portions of 3 epicardial coronary artery and left main artery including the assessment of fibrous cap thickness and lipid pool for vulnerable plaques by OCT. In addition, the investigators will compare the changes such as plaques and neointimal coverage from serial OCT follow-up according to the different statin strategy.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-17
• Primary Completion: 2014-03
• Study Completion: 2014-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient is ≥ 20 years old
• Patients with typical angina who are considered for coronary revascularization.
• Multi-vessel diseases: more than 2 significant coronary de novo lesions (> 70% by quantitative angiographic analysis); one of the target lesions is the most significant tight stenotic lesion causing the ischemic symptom and requiring the immediate revascularization but the others are significant but non-tight lesions to be delayed or observed for 3 months and not requiring immediate PCI for the complete revascularization of all coronary arteries.

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Exclusion Criteria

• ST-elevation MI
• Cardiogenic shock or hemodynamically unstable status
• Lesions requiring the immediate complete revascularization of all coronary stenotic lesions
• Contraindication to anti-platelet agents
• Treated with any DES within 6 months at other vessel
• Creatinine level ≥ 2.0 mg/dL or ESRD
• Severe hepatic dysfunction (3 times normal reference values)
• Pregnant women or women with potential childbearing
• Life expectancy 1 year
• Complex lesion morphologies (bifurcation lesions treated with 2-stent techniques, untreated significant unprotected left main diseases, chronic total occlusion, in-stent restenosis, and vein graft lesion)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pravastatin group	Pravastatin 20mg	-
Xience group	Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA)	-
Cypher group	Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL)	-
Atorvastatin group	Atorvastatin 40mg	-

Primary Outcome Measures

Name	Time	Method
neointimal coverage according to the implanted DES; Xience vs. Cypher	up to 12month after stent implantation	Neointimal coverage means percentage of uncovered struts on OCT. The percentages of uncovered struts were compared between EES and SES.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of