Assessment of Stent Malapposition and Neointimal Coverage on Optical coHerence Tomography at Post-procedure and 3 Months After Platinum Chromium Alloy Of the Element™ Stent Implantation (ANCHOR)

This study is currently recruiting participants.

Verified April 2012 by Yonsei University

Sponsor:

Information provided by (Responsible Party):

Myeong-Ki Hong, Yonsei University

ClinicalTrials.gov Identifier:

NCT01581515

First received: April 11, 2012

Last updated: April 17, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 11, 2012

Last Updated Date

April 17, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the ratio of the malapposed strut [ Time Frame: Participants will be followed from first OCT invervention to 3month OCT following intervention ] [ Designated as safety issue: No ]

The ratio of the malapposed strut, on an immediate OCT after nominal stent pressure and at a final post-procedure between two different DES; ANCHOR-I

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01581515 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of stent malapposition [ Time Frame: 3months OCT following intervention ] [ Designated as safety issue: No ]
Neointimal coverage(ANCHOR II) [ Time Frame: 3 month-OCT after stent implantation ] [ Designated as safety issue: No ]
Incidence of plaque prolapse [ Time Frame: final postprocedural OCT ] [ Designated as safety issue: No ]
Evaluation of stent expansion [ Time Frame: an immediate and post-procedural OCT ] [ Designated as safety issue: No ]
Stent malapposition [ Time Frame: on 3 month OCT intervention ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Assessment of Stent Malapposition and Neointimal Coverage on Optical coHerence Tomography at Post-procedure and 3 Months After Platinum Chromium Alloy Of the Element™ Stent Implantation

Official Title ^ICMJE

2-phased Randomized Comparison Between PromusTMElementTM Versus Xience PRIME® Stent

Brief Summary

The purpose of this study is to compare the degree of stent malapposition on an immediate optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with the randomly assigned two drug-eluting stents (DES), PromusTMElementTM stents versus Xience PRIME® stents.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Device: Promus Element everolimus eluting coronary stent
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
Device: Xience Prime everolimus eluting coronary stent
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime

Study Arm (s)

Active Comparator: P-E group
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime

Intervention: Device: Promus Element everolimus eluting coronary stent
Active Comparator: X-P group
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime

Intervention: Device: Xience Prime everolimus eluting coronary stent

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient is ≥ 20 years old
Significant coronary de novo lesion (> 70% by quantitative angiographic analysis) treated by single DES in each vessel.
Patients with stable angina who are considered for coronary revascularization with stent implantation.
Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion Criteria:

Complex lesion morphologies such as aorto-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
Reference vessel diameter < 2.5 mm or > 4.0mm and lesion length > 28 mm
Heavy calcified lesions (definite calcified lesions on angiogram)
Lesions requiring more than 2 DES in each vessel
Acute coronary syndrome
Contraindication to anti-platelet agents
Treated with any DES within 3 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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Myeong-Ki Hong, MD.PhD.

+82 2 2228 8458

mkhong61@yuhs.ac

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01581515

Other Study ID Numbers ^ICMJE

1-2011-0080

Has Data Monitoring Committee

Yes

Responsible Party

Myeong-Ki Hong, Yonsei University

Study Sponsor ^ICMJE

Yonsei University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Myeong-Ki Hong, MD.PhD.

Severance Hospital

Information Provided By

Yonsei University

Verification Date

April 2012

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

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