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)

April 17, 2012 updated by: Myeong-Ki Hong, Yonsei University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seodaemun-gu/Sinchon-dong
      • Seoul, Seodaemun-gu/Sinchon-dong, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital
        • Contact:
          • Shin-young Park, Staff
          • Phone Number: +82 2 2228 0453
          • Email: smile@yuhs.ac
        • Principal Investigator:
          • Myeong-Ki Hong, MD.PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the ratio of the malapposed strut
Time Frame: Participants will be followed from first OCT invervention to 3month OCT following intervention
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
Participants will be followed from first OCT invervention to 3month OCT following intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of stent malapposition
Time Frame: 3months OCT following intervention
3months OCT following intervention
Neointimal coverage(ANCHOR II)
Time Frame: 3 month-OCT after stent implantation
3 month-OCT after stent implantation
Incidence of plaque prolapse
Time Frame: final postprocedural OCT
final postprocedural OCT
Evaluation of stent expansion
Time Frame: an immediate and post-procedural OCT
an immediate and post-procedural OCT
Stent malapposition
Time Frame: on 3 month OCT intervention
on 3 month OCT intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Myeong-Ki Hong, MD.PhD., Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 17, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

April 20, 2012

Last Update Submitted That Met QC Criteria

April 17, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2011-0080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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