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An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent. (NEVO II)

NCT01202058 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2012-10-25

No results posted yet for this study

Summary

As a result of the implementation of Protocol Am3.0, the design and objective of the NEVO II trial were changed to focus on the safety follow-up of the 103 NEVO™ subjects. Although this trial started interventional, the remainder of the study will be observational.

The objective of this prospective, observational study is to ensure the safety and the wellbeing of subjects treated with the NEVO™ SES.

Conditions

  • Atherosclerotic Coronary Artery Disease

Interventions

DEVICE

NEVO™ Sirolimus-eluting Coronary Stent System

Design Original Protocol Intervention will consist of percutaneous coronary intervention for treatment of a single or multiple coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the NEVO™ Sirolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.

DEVICE

XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System)

Intervention will consist of percutaneous coronary intervention for treatment of a single or multiple coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Patrick W. Serruys, MD, PhD · Erasmus MC - Thoraxcenter, Rotterdam, The Netherlands

  • Stephan Windecker, MD, PhD · Inselspital, Bern, Switzerland

  • Manel Sabate, MD · Hospital Universitari Clinic de Barcelona, Barcelona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-11-30
Completion
2012-10-31

Countries

  • Netherlands
  • Spain
  • Switzerland

Study Locations

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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 NCT01202058 on ClinicalTrials.gov