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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Seoul National University Hospital
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01605721
First received: July 18, 2011
Last updated: May 21, 2012
Last verified: May 2012

July 18, 2011
May 21, 2012
May 2011
April 2013   (final data collection date for primary outcome measure)
Target Lesion Failure (TLF) rate at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01605721 on ClinicalTrials.gov Archive Site
  • In-stent & In-segment Late Loss at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and any MI up to 3 years [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and any MI up to 3 years [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • procedural success up to 1 day [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    failure : CK-MB of >3 times the upper limit of normal
  • angiographic success up to 1 day [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    success : a minimum stenosis diameter reduction to <20% in the presence of grade 3 TIMI flow (assessed by angiography)
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)
Not Provided

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
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Device: XIENCE PRIMETM everolimus-eluting coronary stent

Active prospective registration of patients receiving the following stent

: XIENCE PRIMETM

Experimental: XIENCE PRIMETM everolimus-eluting coronary stent
Intervention: Device: XIENCE PRIMETM everolimus-eluting coronary stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
April 2015
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Kyung-Woo Park, MD, PhD 82-2-2072-0244 kwparkmd@snu.ac.kr
Korea, Republic of
 
NCT01605721
H-1101-054-347
Yes
Hyo-Soo Kim, Seoul National University Hospital
Seoul National University Hospital
Abbott
Study Chair: Hyo-Soo Kim, MD, PhD Seoul National University Hospital
Seoul National University Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP