Stereotaxis and Chronic Total Occlusion

Chronic Total Coronary Occlusion Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980537
• Other study ID #: Stereotaxis and CTO
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: November 4, 2013
• Start date: April 2008

Study information

• Verified date: November 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: AGES (Österreichische Agentur für Gesundheit und Ernährungssicherheit) - Austrian Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Total Coronary Occlusion
• Coronary Occlusion

Intervention

Procedure:
• Magnetic wire navigation

• Conventional wire navigation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of contrast medium		8 hours	Yes