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

This study is currently recruiting participants.
Verified May 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01856374
First received: May 9, 2013
Last updated: May 16, 2013
Last verified: May 2013

May 9, 2013
May 16, 2013
August 2011
January 2014   (final data collection date for primary outcome measure)
neointimal coverage according to the implanted DES; Xience vs. Cypher [ Time Frame: up to 12month after stent implantation ] [ Designated as safety issue: No ]
Neointimal coverage means percentage of uncovered struts on OCT. The percentages of uncovered struts were compared between EES and SES.
Same as current
Complete list of historical versions of study NCT01856374 on ClinicalTrials.gov Archive Site
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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
Not Provided

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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multi-vessel Diseases, Angina
  • Device: Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL)
    Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience Prime® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg.
  • Device: Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA)
    Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience Prime® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg.
  • Drug: Pravastatin 20mg
    2x2 randomization by the treatment of dyslipidemia (In patients of dyslipidemia: pravastatin 20mg/day vs. atorvastatin 40mg and the types of the implanted cypher vs xience.
  • Drug: Atorvastatin 40mg
    2x2 randomization by the treatment of dyslipidemia (In patients of dyslipidemia: pravastatin 20mg/day vs. atorvastatin 40mg and the types of the implanted cypher vs xience.
  • Active Comparator: Cypher group
    Intervention: Device: Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL)
  • Experimental: Xience group
    Intervention: Device: Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA)
  • Active Comparator: Pravastatin group
    Intervention: Drug: Pravastatin 20mg
  • Experimental: Atorvastatin group
    Intervention: Drug: Atorvastatin 40mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
April 2014
January 2014   (final data collection date for primary outcome measure)

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.

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)
Both
20 Years and older
No
Contact: Myeong-Ki Hong, MD, PhD 82-2-2228-8460 mkhong61@yuhs.ac
Korea, Republic of
 
NCT01856374
1-2010-0052
No
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP