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Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTO

NCT00482742 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-07-09

No results posted yet for this study

Summary

The main objectives of the study are:

To evaluate the performance and safety of the CiTop guidewire, while attempting to cross thru total occlusions of various dimensions and morphology.

To compare the safety and efficacy of the CiTop guidewire with standard guidewires in terms of impact on the treated artery. Following operation of the CiTop device, angiography demonstrated successful crossing of the occlusion with no visible evidence of arterial wall injury, dissection, or distal embolization.

To assess ease of operation and the level of integration of the CiTop with standard interventional angiography procedure: Balloon angioplasty, placement of stent.

Conditions

  • Catheterization, Peripheral

Interventions

DEVICE

CiTop(TM) Guidewire

Sponsors & Collaborators

  • Ovalum

    lead INDUSTRY

Principal Investigators

  • Alexander Belenky, MD · Research Fund, Belinson Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Croatia
  • Israel

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 NCT00482742 on ClinicalTrials.gov