NCT01980537

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
Last Updated

November 11, 2013

Status Verified

November 1, 2013

Enrollment Period

3 years

First QC Date

October 24, 2013

Last Update Submit

November 4, 2013

Conditions

Chronic Total Coronary Occlusion

Outcome Measures

Primary Outcomes (1)

  • level of contrast medium

    8 hours

Study Arms (2)

Stereotaxis

EXPERIMENTAL

Magnetic wire navigation

Procedure: Magnetic wire navigation

Conventional

ACTIVE COMPARATOR

Conventional wire navigation

Procedure: Conventional wire navigation

Interventions

Magnetic wire navigationPROCEDURE
Stereotaxis
Conventional wire navigationPROCEDURE
Conventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • chronic renal failure
  • prior allergic reactions against contrast agent
  • hyperthyreosis
  • claustrophobia
  • pregnancy
  • contraindications to aspirin or clopidogrel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. Dr.

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 11, 2013

Study Start

April 1, 2008

Primary Completion

April 1, 2011

Last Updated

November 11, 2013

Record last verified: 2013-11