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Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)

NCT01605721 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2012-05-25

No results posted yet for this study

Summary

Objectives:

1. To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE PRIMETM in a cohort of "real world" patients and lesion subsets.
2. To determine clinical device and procedural success during commercial use of XIENCE PRIMETM coronary stent

Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM

Study period

* 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

Conditions

Interventions

DEVICE

XIENCE PRIMETM everolimus-eluting coronary stent

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

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Hyo-Soo Kim, MD, PhD · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-04-30
Completion
2015-04-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01605721 on ClinicalTrials.gov