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. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Multi-vessel Diseases, Angina
Device: Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL)
Device: Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA)
Drug: Pravastatin 20mg
Drug: Atorvastatin 40mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cypher group 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.
Experimental: Xience group 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.
Active Comparator: Pravastatin group 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.
Experimental: Atorvastatin group 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856374

Contacts
Contact: Myeong-Ki Hong, MD, PhD 82-2-2228-8460 mkhong61@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Myeong-Ki Hong, MD, PhD    82-2-2228-8460    mkhong61@yuhs.ac   
Principal Investigator: Myeong-Ki Hong, MD, PhD         
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01856374     History of Changes
Other Study ID Numbers: 1-2010-0052
Study First Received: May 9, 2013
Last Updated: May 16, 2013
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Atorvastatin
Pravastatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 22, 2014