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XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

NCT01721096 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 536

Last updated 2019-12-20

Study results available
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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

Interventions

DEVICE

XIENCE PRIME - Long Length (LL)

Long Length

DEVICE

XIENCE PRIME - Core Size

Core Size

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ken Kozuma, MD · Teikyo University Hospital, Tokyo

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-06-30
Completion
2018-11-30

Countries

  • Japan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01721096 on ClinicalTrials.gov