Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)
NCT ID: NCT01605721
Last Updated: 2012-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
2000 participants
INTERVENTIONAL
2011-05-31
2015-04-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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XIENCE PRIMETM everolimus-eluting coronary stent
XIENCE PRIMETM everolimus-eluting coronary stent
Active prospective registration of patients receiving the following stent
: XIENCE PRIMETM
Interventions
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XIENCE PRIMETM everolimus-eluting coronary stent
Active prospective registration of patients receiving the following stent
: XIENCE PRIMETM
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Hyo-Soo Kim
MD PhD
Principal Investigators
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Hyo-Soo Kim, MD, PhD
Role: STUDY_CHAIR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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H-1101-054-347
Identifier Type: -
Identifier Source: org_study_id
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