Iliac, Common and External (ICE) Artery Stent Trial

NCT01305174 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2016-09-30

No results posted yet for this study

Summary

The objective of this prospective, randomized,controlled and multicenter trial is, to compare recurrent-restenosis rates in the balloon expandable VISIO-PRO stent arm and the selfexpandable PROTEGE GPS stent arm 12 month after treatment of stenosis or occlusions of common and external iliac artery disease.

Conditions

  • Vascular Lesions

Interventions

DEVICE

PROTEGE GPS stent vs. VISI-PRO stent

Visi-Pro balloon expandable stent vs. PROTEGE GPS selfexpanding nitinol stent to treat stenosis or occlusion of common and external iliac artery disease

Sponsors & Collaborators

  • Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

    lead OTHER

Principal Investigators

  • Hans Krankenberg, Dr. · Medical Care Center Prof. Mathey, Prof. Schofer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-07-31
Completion
2014-07-31

Countries

  • Germany

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 NCT01305174 on ClinicalTrials.gov