NCT01605721

Brief Summary

Objectives:

  • Patient enrollment: 2011.05 \~ 2012.04
  • End of follow-up period: 2015. 02 (3 years of follow-up) Primary endpoint : Target Lesion Failure (TLF) rate at 12 months Secondary endpoint:
  • In-stent \& In-segment Late Loss at 9 months
  • Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)
  • Target Vessel Failure at 12 months (composite of cardiac death, MI, and TVR)
  • Any death, cardiac death, MI, TLR, TVR at 30 days, 9months, 1 year, 3 years
  • Composite rate of cardiac death and any MI up to 3 years
  • Composite rate of all death and any MI up to 3 years
  • Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years
  • Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years
  • Procedural success up to 1 day
  • Angiographic success up to 1 day

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
2,000

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started May 2011

Typical duration for phase_4 coronary-artery-disease

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

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 25, 2012

Status Verified

May 1, 2012

Enrollment Period

1.9 years

First QC Date

July 18, 2011

Last Update Submit

May 21, 2012

Conditions

Coronary Artery Disease

Keywords

EverolimusXIENCE PRIMEDrug eluting stent

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Failure (TLF) rate at 12 months

    12 months

Secondary Outcomes (9)

  • In-stent & In-segment Late Loss at 9 months

    9 months

  • Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)

    24 hours, 30 days, up to 3 years

  • Any death, cardiac death, MI, TLR, TVR at 30 days, 9 months, 1 year, 3 years

    30 days, 9 months, 1 year, up to 3 years

  • Composite rate of cardiac death and any MI up to 3 years

    up to 3 years

  • Composite rate of all death and any MI up to 3 years

    up to 3 years

  • +4 more secondary outcomes

Study Arms (1)

XIENCE PRIMETM everolimus-eluting coronary stent

EXPERIMENTAL
Device: XIENCE PRIMETM everolimus-eluting coronary stent

Interventions

XIENCE PRIMETM everolimus-eluting coronary stentDEVICE

Active prospective registration of patients receiving the following stent : XIENCE PRIMETM

XIENCE PRIMETM everolimus-eluting coronary stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

  • Kang J, Han JK, Kang DY, Zheng C, Yang HM, Park KW, Kang HJ, Koo BK, Kim HS. SYNTAX Score and SYNTAX Score II Can Predict the Clinical Outcomes of Patients with Left Main and/or 3-Vessel Disease Undergoing Percutaneous Coronary Intervention in the Contemporary Cobalt-Chromium Everolimus-Eluting Stent Era. Korean Circ J. 2020 Jan;50(1):22-34. doi: 10.4070/kcj.2019.0097. Epub 2019 Sep 30.

    PMID: 31642213DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Hyo-Soo Kim, MD, PhD

    Seoul National University Hospital

    STUDY CHAIR

Central Study Contacts

Kyung-Woo Park, MD, PhD

CONTACT

82-2-2072-0244kwparkmd@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

July 18, 2011

First Posted

May 25, 2012

Study Start

May 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2015

Last Updated

May 25, 2012

Record last verified: 2012-05

Locations

KR(1)