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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)

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Promus Element everolimus eluting coronary stent
Xience Prime everolimus eluting coronary stent
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

P-E group

X-P group

Arm Description

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

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

Outcomes

Primary Outcome Measures

the ratio of the malapposed strut
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

Secondary Outcome Measures

Incidence of stent malapposition
Neointimal coverage(ANCHOR II)
Incidence of plaque prolapse
Evaluation of stent expansion
Stent malapposition

Full Information

First Posted
April 11, 2012
Last Updated
April 17, 2012
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01581515
Brief Title
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
Acronym
ANCHOR
Official Title
2-phased Randomized Comparison Between PromusTMElementTM Versus Xience PRIME® Stent
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P-E group
Arm Type
Active Comparator
Arm Description
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
Arm Title
X-P group
Arm Type
Active Comparator
Arm Description
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
Intervention Type
Device
Intervention Name(s)
Promus Element everolimus eluting coronary stent
Intervention Description
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
Intervention Type
Device
Intervention Name(s)
Xience Prime everolimus eluting coronary stent
Intervention Description
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
Primary Outcome Measure Information:
Title
the ratio of the malapposed strut
Description
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
Time Frame
Participants will be followed from first OCT invervention to 3month OCT following intervention
Secondary Outcome Measure Information:
Title
Incidence of stent malapposition
Time Frame
3months OCT following intervention
Title
Neointimal coverage(ANCHOR II)
Time Frame
3 month-OCT after stent implantation
Title
Incidence of plaque prolapse
Time Frame
final postprocedural OCT
Title
Evaluation of stent expansion
Time Frame
an immediate and post-procedural OCT
Title
Stent malapposition
Time Frame
on 3 month OCT intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myeong-Ki Hong, MD.PhD.
Phone
+82 2 2228 8458
Email
mkhong61@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myeong-Ki Hong, MD.PhD.
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
State/Province
Seodaemun-gu/Sinchon-dong
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shin-young Park, Staff
Phone
+82 2 2228 0453
Email
smile@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Myeong-Ki Hong, MD.PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25345751
Citation
Kim BK, Shin DH, Kim JS, Ko YG, Choi D, Jang Y, Hong MK. Randomized comparison of acute stent malapposition between platinum-chromium versus cobalt-chromium everolimus-eluting stents. Int J Cardiovasc Imaging. 2015 Feb;31(2):269-77. doi: 10.1007/s10554-014-0557-y. Epub 2014 Oct 28.
Results Reference
derived

Learn more about this trial

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

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