ComparisiOn of Neointimal coVerage betwEen ZES and EES Using OCT at 3 Months

NCT01091740 | Completed Phase 4 DMC

• 1 other identifier: 1-2009-0010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study try to 1) evaluate the neointimal coverage and malapposition at 3 month after new zotarolimus eluting stent (Endeavor resolute) and everolimus eluting stent (Xience) implantation and 2) compare them between ZES resolute and EES at 3 months (early period) after stent implantation.

Conditions

Coronary Artery Disease

Keywords

Drug eluting stent; Tomography, optical coherence

Outcome Measures

Primary Outcomes (1)

• The rate of neointimal coverage between ZES resolute and EES at 3 months after stent implantation by OCT.

  3 months after stent implantation

Secondary Outcomes (2)

• Neointimal growth between ZES resolute and EES at 3 months after stent by OCT.

  3 months after stent implantation

• Early malapposition just after stent implantation and late malapposition at 3 months after stent implantaiton between ZES resolute and EES by OCT.

  3 months after stent implantation

Study Arms (2)

ZES resolute (Endeavor Resolute)

EXPERIMENTAL

Device: ZES resolute (Endeavor Resolute)

EES (Xience)

ACTIVE COMPARATOR

Device: EES (Xience)

Interventions

ZES resolute (Endeavor Resolute) DEVICE

2nd generation drug eluting stent, which is coated with zotarolimus

Also known as: Endeavor resolute

ZES resolute (Endeavor Resolute)

EES (Xience) DEVICE

2nd generation drug eluting stent, which is coated with everolimus

Also known as: Xience

EES (Xience)

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis)
• Patients with stable angina pectoris who are considered for coronary revascularization.
• Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

You may not qualify if:

• Acute coronary syndrome
• Contraindication to anti-platelet agents
• Proximal leison within 15 mm from ostium
• Treated with any DES within 1 year 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
• Complex lesion morphologies (aorto-ostial, unprotected Left main, chronic total occlusion)
• Target lesion is vein graft lesion
• Reference vessel \< 2.5 mm or \> 4.0mm diameter by visual

Sponsors & Collaborators

• Yonsei University: lead
• Medtronic: collaborator

Study Sites (2)

Dongsan Medical Center, Keimyung University College of Medicine

Daegu, 700-712, South Korea

Location

Division of Cardiology, Cardiovascular Hospital, Yonsei University

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jung-Sun Kim, MD, Ph D

  Division of Cardiology, Cardiovascular Hospital, Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 24, 2010
• Study Start: August 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

KR (2)