MedDataX Logo

XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

NCT ID: NCT01721096

Last Updated: 2019-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

536 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Angina Coronary Occlusion Coronary Artery Disease Coronary Artery Stenosis Myocardial Ischemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Angioplasty Drug eluting stents Stents Real world

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

XIENCE PRIME - Long Length (LL)

Intervention Type DEVICE

Long Length

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.

XIENCE PRIME - Core Size

Intervention Type DEVICE

Core Size

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

XIENCE PRIME - Long Length (LL)

Long Length

Intervention Type DEVICE

XIENCE PRIME - Core Size

Core Size

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ken Kozuma, MD

Role: STUDY_CHAIR

Teikyo University Hospital, Tokyo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Abbott Vascular Japan Co., Ltd.

Tokyo, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-398

Identifier Type: -

Identifier Source: org_study_id