NCT01581515

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

2 years

First QC Date

April 11, 2012

Last Update Submit

April 17, 2012

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    Participants will be followed from first OCT invervention to 3month OCT following intervention

Secondary Outcomes (5)

  • Incidence of stent malapposition

    3months OCT following intervention

  • Neointimal coverage(ANCHOR II)

    3 month-OCT after stent implantation

  • Incidence of plaque prolapse

    final postprocedural OCT

  • Evaluation of stent expansion

    an immediate and post-procedural OCT

  • Stent malapposition

    on 3 month OCT intervention

Study Arms (2)

P-E group

ACTIVE COMPARATOR

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

X-P group

ACTIVE COMPARATOR

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

Interventions

Promus Element everolimus eluting coronary stentDEVICE

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

P-E group
Xience Prime everolimus eluting coronary stentDEVICE

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

X-P group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu/Sinchon-dong, 120-752, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25345751DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Myeong-Ki Hong, MD.PhD.

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Myeong-Ki Hong, MD.PhD.

CONTACT

+82 2 2228 8458mkhong61@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph D

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 20, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

KR(1)