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Stereotaxis and Chronic Total Occlusion

NCT ID: NCT01980537

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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Wire-crossing of a chronic total coronary occlusion (CTO) is time-consuming and limited by the amount of contrast agent and time of radiation exposure. Magnetic wire navigation might accelerate wire-crossing by maintaining a coaxial vessel orientation. This study compares magnetic with conventional wire navigation for recanalization of CTOs.

Detailed Description

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Conditions

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Chronic Total Coronary Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Stereotaxis

Magnetic wire navigation

Group Type EXPERIMENTAL

Magnetic wire navigation

Intervention Type PROCEDURE

Conventional

Conventional wire navigation

Group Type ACTIVE_COMPARATOR

Conventional wire navigation

Intervention Type PROCEDURE

Interventions

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Magnetic wire navigation

Intervention Type PROCEDURE

Conventional wire navigation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* symptomatic
* preserved wall motion or viable myocardium
* chronic total occlusion

Exclusion Criteria

* chronic renal failure
* prior allergic reactions against contrast agent
* hyperthyreosis
* claustrophobia
* pregnancy
* contraindications to aspirin or clopidogrel
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Univ. Prof. Dr. Thomas Neunteufl

Univ. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Stereotaxis and CTO

Identifier Type: -

Identifier Source: org_study_id