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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
XIENCE PRIMETM everolimus-eluting coronary stent
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Everolimus, XIENCE PRIME, Drug eluting stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XIENCE PRIMETM everolimus-eluting coronary stent

Arm Description

Outcomes

Primary Outcome Measures

Target Lesion Failure (TLF) rate at 12 months

Secondary Outcome Measures

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)
Any death, cardiac death, MI, TLR, TVR at 30 days, 9 months, 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
failure : CK-MB of >3 times the upper limit of normal
angiographic success up to 1 day
success : a minimum stenosis diameter reduction to <20% in the presence of grade 3 TIMI flow (assessed by angiography)

Full Information

First Posted
July 18, 2011
Last Updated
May 21, 2012
Sponsor
Seoul National University Hospital
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT01605721
Brief Title
Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objectives: 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Everolimus, XIENCE PRIME, Drug eluting stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XIENCE PRIMETM everolimus-eluting coronary stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
XIENCE PRIMETM everolimus-eluting coronary stent
Intervention Description
Active prospective registration of patients receiving the following stent : XIENCE PRIMETM
Primary Outcome Measure Information:
Title
Target Lesion Failure (TLF) rate at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
In-stent & In-segment Late Loss at 9 months
Time Frame
9 months
Title
Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)
Time Frame
24 hours, 30 days, up to 3 years
Title
Any death, cardiac death, MI, TLR, TVR at 30 days, 9 months, 1 year, 3 years
Time Frame
30 days, 9 months, 1 year, up to 3 years
Title
Composite rate of cardiac death and any MI up to 3 years
Time Frame
up to 3 years
Title
Composite rate of all death and any MI up to 3 years
Time Frame
up to 3 years
Title
Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years
Time Frame
up to 3 years
Title
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years
Time Frame
up to 3 years
Title
procedural success up to 1 day
Description
failure : CK-MB of >3 times the upper limit of normal
Time Frame
1 day
Title
angiographic success up to 1 day
Description
success : a minimum stenosis diameter reduction to <20% in the presence of grade 3 TIMI flow (assessed by angiography)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung-Woo Park, MD, PhD
Phone
82-2-2072-0244
Email
kwparkmd@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo-Soo Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyung-Woo Park, MD, PhD
Phone
82-2-2072-0244
Email
kwparkmd@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Hyo-Soo Kim, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31642213
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.
Results Reference
derived

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

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