Chronic Total Coronary OcclusionNCT01980537
Stereotaxis and Chronic Total Occlusion
A study testing Magnetic wire navigation and Conventional wire navigation in people with Chronic Total Coronary Occlusion, run by Medical University of Vienna.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Coronary Occlusion
- What is being tested?
- Magnetic wire navigation and Conventional wire navigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic
- preserved wall motion or viable myocardium
- chronic total occlusion
Who cannot join
- chronic renal failure
- prior allergic reactions against contrast agent
- hyperthyreosis
- claustrophobia
- pregnancy
- contraindications to aspirin or clopidogrel
About this study
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.
- Conditions
- Chronic Total Coronary Occlusion
- Being tested
- Magnetic wire navigation, Conventional wire navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic wire navigationProcedure or surgery
Conventional wire navigationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Stereotaxis | Experimental | Magnetic wire navigation Receives: Procedure: Magnetic wire navigation |
| Conventional | Active comparator | Conventional wire navigation Receives: Procedure: Conventional wire navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of contrast medium
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startApr 2008
- Primary completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Coronary OcclusionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ. Prof. Dr. Thomas Neunteufl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980537
- Sponsor's protocol ID
- Stereotaxis and CTO
- Status last verified
- Nov 2013
- First submitted
- 24 Oct 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotaxis and Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT01980537
- Acronym / sponsor ID
- Stereotaxis and CTO
- Conditions
- Chronic Total Coronary Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2011 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotaxis | Experimental | Procedure: Magnetic wire navigationMagnetic wire navigation |
| Conventional | Active comparator | Procedure: Conventional wire navigationConventional wire navigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- symptomatic
- preserved wall motion or viable myocardium
- chronic total occlusion
Key exclusion criteria (6 listed)
- chronic renal failure
- prior allergic reactions against contrast agent
- hyperthyreosis
- claustrophobia
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic wire navigation | Procedure or surgery | Stereotaxis |
| Conventional wire navigation | Procedure or surgery | Conventional |
Primary outcome
level of contrast medium
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic wire navigation and Conventional wire navigation in people with Chronic Total Coronary Occlusion, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of contrast medium (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.