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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.
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
History of Changes
  Purpose

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

Condition Intervention Phase
Coronary Artery Disease
 Device: XIENCE PRIMETM everolimus-eluting coronary stent
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Target Lesion Failure (TLF) rate at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 2000
Study Start Date: May 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XIENCE PRIMETM everolimus-eluting coronary stent Device: XIENCE PRIMETM everolimus-eluting coronary stent

Active prospective registration of patients receiving the following stent

: XIENCE PRIMETM

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605721

Contacts
Contact: Kyung-Woo Park, MD, PhD 82-2-2072-0244 kwparkmd@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyung-Woo Park, MD, PhD     82-2-2072-0244     kwparkmd@snu.ac.kr    
Principal Investigator: Hyo-Soo Kim, MD, PhD            
Sponsors and Collaborators
Seoul National University Hospital
Abbott
Investigators
Study Chair: Hyo-Soo Kim, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Hyo-Soo Kim, MD PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01605721     History of Changes
Other Study ID Numbers: H-1101-054-347
Study First Received: July 18, 2011
Last Updated: May 21, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Everolimus
XIENCE PRIME
Drug eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013