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XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan

NCT01086228 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2010

Last updated 2018-02-19

Study results available
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Summary

The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.

Conditions

  • Angina
  • Chronic Coronary Occlusion
  • Stent Thrombosis
  • Vascular Disease
  • Myocardial Ischemia
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Restenosis

Interventions

DEVICE

XIENCE V / PROMUS stent

Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Gary Thompson · Abbott Medical Devices

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-06-30
Completion
2016-08-31

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 NCT01086228 on ClinicalTrials.gov