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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: November 5, 2014
Last verified: November 2014
  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 Length

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:
  • Stent thrombosis (ST) [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]
    Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition.

  • Stent thrombosis (ST) [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]
    Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition.

  • Stent thrombosis (ST) [ Time Frame: 2 years post index procedure ] [ Designated as safety issue: Yes ]
    Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition.

  • Stent thrombosis (ST) [ Time Frame: 3 years post index procedure ] [ Designated as safety issue: Yes ]
    Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition.

  • Stent thrombosis (ST) [ Time Frame: 4 years post index procedure ] [ Designated as safety issue: Yes ]
    Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition.

  • Stent thrombosis (ST) [ Time Frame: 5 years post index procedure ] [ Designated as safety issue: Yes ]
    Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition.

  • Adverse events (AE) caused by Anti-platelet Medications [ Time Frame: 8 months post index procedure ] [ Designated as safety issue: Yes ]

    AE caused by Antiplatelet medications include but not limited to

    • Hepatic disorder
    • Granulocytopenia
    • Thrombotic Thrombocytopenic Purpura

  • Adverse events (AE) caused by Anti-platelet Medications [ Time Frame: 1 year post index procedure ] [ Designated as safety issue: Yes ]

    AE caused by Antiplatelet medications include but not limited to

    • Hepatic disorder
    • Granulocytopenia
    • Thrombotic Thrombocytopenic Purpura

  • Adverse events (AE) caused by Anti-platelet Medications [ Time Frame: 2 years post index procedure ] [ Designated as safety issue: Yes ]

    AE caused by Antiplatelet medications include but not limited to

    • Hepatic disorder
    • Granulocytopenia
    • Thrombotic Thrombocytopenic Purpura

  • Adverse events (AE) caused by Anti-platelet Medications [ Time Frame: 3 years post index procedure ] [ Designated as safety issue: Yes ]

    AE caused by Antiplatelet medications include but not limited to

    • Hepatic disorder
    • Granulocytopenia
    • Thrombotic Thrombocytopenic Purpura

  • Adverse events (AE) caused by Anti-platelet Medications [ Time Frame: 4 years post index procedure ] [ Designated as safety issue: Yes ]

    AE caused by Antiplatelet medications include but not limited to

    • Hepatic disorder
    • Granulocytopenia
    • Thrombotic Thrombocytopenic Purpura

  • Adverse events (AE) caused by Anti-platelet Medications [ Time Frame: 5 years post index procedure ] [ Designated as safety issue: Yes ]

    AE caused by Antiplatelet medications include but not limited to

    • Hepatic disorder
    • Granulocytopenia
    • Thrombotic Thrombocytopenic Purpura


Estimated Enrollment: 500
Study Start Date: November 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
XIENCE PRIME - Long Length (LL)
300 patients receiving LL stent in 28, 33, or 38 mm length
Device: XIENCE PRIME - Long Length (LL)
Long Length
XIENCE PRIME - Core Length
200 patients with 8, 12, 15, 18 or 23 mm stents
Device: XIENCE PRIME - Core Length
Core Length

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 PMDA.

  Eligibility

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

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01721096     History of Changes
Other Study ID Numbers: 12-398
Study First Received: September 20, 2012
Last Updated: November 5, 2014
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
Coronary Disease
Coronary Occlusion
Coronary Stenosis
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014