Clinical trial NCT01605721: Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Everolimus
XIENCE PRIME
Drug eluting stent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2012-05-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria

* 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.

Angiographic Inclusion Criteria

* There are no angiographic inclusion criteria for this study.

Exclusion criteria

* There are no exclusion criteria for this study.

Primary outcomes:
measure: Target Lesion Failure (TLF) rate at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: In-stent & In-segment Late Loss at 9 months
timeFrame: 9 months
measure: Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)
timeFrame: 24 hours, 30 days, up to 3 years
measure: Any death, cardiac death, MI, TLR, TVR at 30 days, 9 months, 1 year, 3 years
timeFrame: 30 days, 9 months, 1 year, up to 3 years
measure: Composite rate of cardiac death and any MI up to 3 years
timeFrame: up to 3 years
measure: Composite rate of all death and any MI up to 3 years
timeFrame: up to 3 years
measure: Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years
timeFrame: up to 3 years
measure: Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years
timeFrame: up to 3 years
measure: procedural success up to 1 day
timeFrame: 1 day
measure: angiographic success up to 1 day
timeFrame: 1 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Soo Kim, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.