Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01721096
First received: September 20, 2012
Last updated: June 7, 2016
Last verified: June 2016
  Purpose
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.

Condition Intervention
Angina
Coronary Occlusion
Coronary Artery Disease
Coronary Artery Stenosis
Myocardial Ischemia
Device: XIENCE PRIME - Long Length (LL)
Device: XIENCE PRIME - Core Size

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: XIENCE PRIME Everolimus Eluting Coronary Stent Post Marketing Surveillance (PMS) in Japan

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Acute Stent Thrombosis (ST) [ Time Frame: Time Frame: Acute (0-24 hours) ] [ Designated as safety issue: Yes ]
    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  • Subacute Stent Thrombosis (ST) [ Time Frame: Subacute (>24 hours to 30 days) ] [ Designated as safety issue: Yes ]
    Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

  • Late Stent Thrombosis (ST) [ Time Frame: Late (>30 days to 1 year) ] [ Designated as safety issue: Yes ]
    Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

  • Overall Stent Thrombosis [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
    Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).


Secondary Outcome Measures:
  • Success Rate: Implant Success Rate by Device [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 5 days ] [ Designated as safety issue: No ]
  • Success Rate: Procedural Success by Lesion [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 5 days ] [ Designated as safety issue: No ]
  • Success Rate: Implant Success by Patient [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 5 days ] [ Designated as safety issue: No ]
  • Composite Endpoint of Target Lesion Failure [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
    Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

  • Composite Endpoint of Target Lesion Failure [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
    Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

  • Composite Endpoint of All Death/All MI/All Revascularization (DMR) [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of All Death/All MI/All Revascularization (DMR) [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Target Vessel Failure [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
    Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

  • Composite Endpoint of Target Vessel Failure [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
    Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

  • Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE) [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).

  • Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE) [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).

  • Composite Endpoint of Death or MI [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Death or MI [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death or MI [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death or MI [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death or Target Vessel MI [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death or Target Vessel MI [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
    Death includes cardiac death, non-cardiac death and non-coronary death.

  • Death [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
    Death includes cardiac death, non-cardiac death and non-coronary death.

  • Myocardial Infarction [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
    The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI

  • Myocardial Infarction [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
    The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI

  • Target Lesion Revascularization [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]

    Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.

    Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.


  • Target Lesion Revascularization [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]

    Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.

    Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.


  • Target Vessel Revascularization (Non-TLR) [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
    Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.

  • Target Vessel Revascularization (Non-TLR) [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
    Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR

  • Target Vessel Revascularization (TLR or TVR Non-TLR) [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
    Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

  • Target Vessel Revascularization (TLR or TVR Non-TLR) [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
    Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

  • Non-target Vessel Revascularization (Non-TVR) [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
    Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.

  • Non-target Vessel Revascularization (Non-TVR) [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
    Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.

  • All Revascularization [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
    All revascularization includes ischemia driven and non-ischemia driven revascularization.

  • All Revascularization [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
    All revascularization includes ischemia driven and non-ischemia driven revascularization.

  • Bleeding [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
  • Bleeding [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
  • Percent Diameter Stenosis (%DS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

  • Percent Diameter Stenosis (%DS) [ Time Frame: Post procedure ] [ Designated as safety issue: No ]
    The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

  • Percent Diameter Stenosis (%DS) [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: No ]
    The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

  • Acute Gain: In-stent, In-segment [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: No ]
    The difference between post- and pre-procedural MLD.

  • Late Loss(LL): In-stent, In-segment, Proximal, and Distal [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: No ]
    Late loss is calculated as MLD post procedure - MLD at follow-up.

  • Net Gain: In-stent, In-segment [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: No ]
    Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).


Enrollment: 536
Study Start Date: October 2012
Estimated Study Completion Date: December 2018
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
XIENCE PRIME - Long Length (LL)
323 patients receiving LL stent in 28, 33, or 38 mm length
Device: XIENCE PRIME - Long Length (LL)
Long Length
XIENCE PRIME - Core Size
213 patients with 8, 12, 15, 18 or 23 mm stents
Device: XIENCE PRIME - Core Size
Core Size

Detailed Description:
The primary objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation by Pharmaceuticals and Medical Devices Agency (PMDA).
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Only patients in Japan, who are eligible to receive treatment for coronary arteries using the XIENCE PRIME Everolimus-Eluting Stent System are to be enrolled.
Criteria

Inclusion Criteria:

  • Patients with ischemic heart disease who are eligible for treatment with XIENCE PRIME Everolimus Eluting Stent
  • Patient provides Informed Consent Form

Exclusion Criteria:

  • If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721096

Locations
Japan
Abbott Vascular Japan Co., Ltd.
Tokyo, Japan, 108-6304
Sponsors and Collaborators
Abbott Vascular
Investigators
Study Chair: Ken Kozuma, MD Teikyo University Hospital, Tokyo
  More Information

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01721096     History of Changes
Other Study ID Numbers: 12-398 
Study First Received: September 20, 2012
Results First Received: July 17, 2015
Last Updated: June 7, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Angioplasty
Drug eluting stents
Stents
Real world

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Coronary Stenosis
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2016