XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

NCT01721096 | Completed Results DMC

• 1 other identifier: 12-398
• Study Type: observational
• Target: 536
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Angina; Coronary Occlusion; Coronary Artery Disease; Coronary Artery Stenosis; Myocardial Ischemia

Keywords

Angioplasty; Drug eluting stents; Stents; Real world

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Acute Stent Thrombosis (ST)

  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).

  Time Frame: Acute (0-24 hours)

• Number of Participants With Subacute Stent Thrombosis (ST)

  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).

  Subacute (>24 hours to 30 days)

• Number of Participants With Late Stent Thrombosis (ST)

  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 (>30 days to 1 year)

• Total Number of Participants With Overall Stent Thrombosis

  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).

  1 year post index procedure

Secondary Outcomes (84)

• Success Rate: Percentage of Participants With Implant Success Rate by Device

  Participants will be followed for the duration of hospital stay, an average of 5 days

• Success Rate: Percentage of Participants With Procedural Success by Lesion

  Participants will be followed for the duration of hospital stay, an average of 5 days

• Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base)

  Participants will be followed for the duration of hospital stay, an average of 5 days

• Number of Participants With Target Lesion Failure (TLF)

  8 months post index procedure

• Number of Participants With Target Lesion Failure (TLF)

  1 year post index procedure

Study Arms (2)

XIENCE PRIME - Long Length (LL)

Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length).There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths.

Device: XIENCE PRIME - Long Length (LL)

XIENCE PRIME - Core Size

Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths.

Device: XIENCE PRIME - Core Size

Interventions

XIENCE PRIME - Long Length (LL) DEVICE

Long Length

XIENCE PRIME - Long Length (LL)

XIENCE PRIME - Core Size DEVICE

Core Size

XIENCE PRIME - Core Size

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular Japan Co., Ltd.

Tokyo, 108-6304, Japan

Location

MeSH Terms

Conditions

Angina Pectoris; Coronary Occlusion; Coronary Artery Disease; Coronary Stenosis; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: David R Rutledge
• Organization: Abbott Vascular

david.rutledge@av.abbott.com

(408) 845-3820

Study Officials

• Ken Kozuma, MD

  Teikyo University Hospital, Tokyo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: November 5, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2018
• Last Updated: December 20, 2019
• Results First Posted: July 19, 2016

Record last verified: 2019-05

Locations

JP (1)