Coronary Artery DiseasePhase 2TOTARNCT01131793
PowerAssert Radio-Frequency (RF) Guidewire Coronary In-Stent Chronic Total Occlusion (CTO)
A Phase 2 study testing PowerAssert RF wire in crossing coronary in-stent chronic total occlusions in people with Coronary Artery Disease, run by Stereotaxis at 1 site in Netherlands.
Trial summary
A single center Pilot Clinical Registry Study of the" Acute Procedural" Safety and Efficacy of Stereotaxis PowerAssert(TM)RF Coronary Total Occlusion System assisted Angioplasty in the Treatment of Refractory Coronary Total Occlusions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PowerAssert RF wire in crossing coronary in-stent chronic total occlusions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2010to Mar 2011
- Phase
- Phase 2
- 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
- Patient eligible for elective revascularization of a native coronary vessel
- Patient has refractory coronary total occlusion (Thrombolysis In Myocardial Infarction (TIMI) 0 flow) within a stent
- Written Informed Consent obtained
Who cannot join
- Under 18 years of age
- Current participation in another study with any investigational drug or device
- ->TIMI 0 flow at target lesion site
- Lesion >40mm. in length
- Factors making follow-up or repeat angiography difficult or unlikely
- Acute myocardial infarction less than 1 month before angioplasty
Show all 16Show fewer
- Contra-indication to emergency coronary artery bypass surgery
- No access to cardiac surgery
- Contra-indication to treatment with aspirin, ticlopidine, clopidogrel or heparin
- Angiographic evidence of thrombus (filling defect proximal to or involving the occlusion)
- Occluded ostium of the right coronary artery or stem of left main coronary artery as target lesion
- Totally occluded bypass graft as target vessel
- Occlusion in an unprotected left main coronary artery
- Ejection fraction less than 30%
- Lesion beyond acute bends or in a location within the coronary anatomy where the catheter cannot traverse
- Lesion within a bifurcation with a significant sidebranch >1.5mm in diameter
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus MC University Medical Center
Rotterdam, The Netherlands
About this study
Official title: Total Occlusion With Angioplasty After Using a Radiofrequency Guide Wire-Magnetic-Coronary
A single center Pilot Clinical Registry Study of the" Acute Procedural" Safety and Efficacy of Stereotaxis PowerAssert(TM)RF Coronary Total Occlusion System assisted Angioplasty in the Treatment of Refractory Coronary Total Occlusions
Read the detailed description
Determine the safety and efficacy of the Stereotaxis PowerAssert™ 18 RF Wire System:
Primary - of recanalizing (crossing) coronary total occlusions within a stent.
Secondary - facilitated angioplasty at hospital discharge represented by
- Event free survival
- Anginal status, and
- Target vessel patency
- minimal luminal diameter (MLD).
- Conditions
- Coronary Artery Disease
- Being tested
- PowerAssert RF wire in crossing coronary in-stent chronic total occlusions
- Keywords
- Coronary Artery Chronic Total Occlusion In-Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PowerAssert RF wire in crossing coronary in-stent chronic total occlusionsDevice
Also called PowerAssert RF, Magnetic RF Wire
Radio frequency ablation of chronic total occlusions within a stent of a coronary artery using Niobe Magnetic Navigation System (MNS) and the PowerAssert Radiofrequency Guidewire
| Study group | Role | What they receive |
|---|---|---|
| RF Guidewire | Experimental | Not described Receives: Device: PowerAssert RF wire in crossing coronary in-stent chronic total occlusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary RF wire success
Defined as reaching the true lumen of any branch distal to the total occlusion with the sole use of the RF wire with absence of major complications (Myocardial Infarction (MI), tamponade, emergency Cornary Artery Bypass graft (CABG) or death)
Measured: Assessed and measured during interventional procedure up to discharge-average hospital stay 1-5 days- defined in protocol as the number of days between interventional treatment and hospital discharge
Secondary outcomes (1)
Facilitated RF wire Success: Procedure Success: Clinical Success
Facilitated RF wire success is defined as reaching the true lumen of any branch distal to the total occlusion with combined use of the RF wire and any approved mechanical guidewire with absence of major complications Procedure success defined as in-hospital device success and final residual stenosis < 30% on visual assessment, following adjunctive angioplasty, with absence of major complications Clinical success defined as device and procedure success during the concurrent hospital stay with absence of major complication
Measured: Assessed and measured during interventional procedure up to discharge-average hospital stay 1-5 days- defined in protocol as the number of days between interventional treatment and hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stereotaxis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Projessor Patrick W. Serruys, PhD, Principal investigator, Erasmus Medical University Thoraxcenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131793
- Sponsor's protocol ID
- CLIN-019
- Acronym
- TOTAR
- Status last verified
- Jul 2011
- First submitted
- 20 May 2010
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Occlusion With Angioplasty After Using a Radiofrequency Guide Wire-Magnetic-Coronary
- ClinicalTrials.gov ID
- NCT01131793
- Acronym / sponsor ID
- TOTAR / CLIN-019
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Chronic Total Occlusion In-Stent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- StereotaxisIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 May 2010 (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.
A single center Pilot Clinical Registry Study of the" Acute Procedural" Safety and Efficacy of Stereotaxis PowerAssert(TM)RF Coronary Total Occlusion System assisted Angioplasty in the Treatment of Refractory Coronary Total Occlusions
Detailed description
Determine the safety and efficacy of the Stereotaxis PowerAssert™ 18 RF Wire System:
Primary - of recanalizing (crossing) coronary total occlusions within a stent.
Secondary - facilitated angioplasty at hospital discharge represented by
- Event free survival
- Anginal status, and
- Target vessel patency
- minimal luminal diameter (MLD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF Guidewire | Experimental | Device: PowerAssert RF wire in crossing coronary in-stent chronic total occlusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient eligible for elective revascularization of a native coronary vessel
- Patient has refractory coronary total occlusion (Thrombolysis In Myocardial Infarction (TIMI) 0 flow) within a stent
- Written Informed Consent obtained
Key exclusion criteria (16 listed)
- Under 18 years of age
- Current participation in another study with any investigational drug or device
- ->TIMI 0 flow at target lesion site
- Lesion >40mm. in length
- Factors making follow-up or repeat angiography difficult or unlikely
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 |
|---|---|---|
| PowerAssert RF wire in crossing coronary in-stent chronic total occlusionsAlso: PowerAssert RF, Magnetic RF WireRadio frequency ablation of chronic total occlusions within a stent of a coronary artery using Niobe Magnetic Navigation System (MNS) and the PowerAssert Radiofrequency Guidewire | Device | RF Guidewire |
Primary outcome
Primary RF wire success
Time frame: Assessed and measured during interventional procedure up to discharge-average hospital stay 1-5 days- defined in protocol as the number of days between interventional treatment and hospital discharge
Defined as reaching the true lumen of any branch distal to the total occlusion with the sole use of the RF wire with absence of major complications (Myocardial Infarction (MI), tamponade, emergency Cornary Artery Bypass graft (CABG) or death)
1 secondary outcome
Facilitated RF wire Success: Procedure Success: Clinical Success
Time frame: Assessed and measured during interventional procedure up to discharge-average hospital stay 1-5 days- defined in protocol as the number of days between interventional treatment and hospital discharge
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 20 Jul 2011.
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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.
Projessor Patrick W. Serruys, PhD principal investigator
Erasmus Medical University Thoraxcenter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PowerAssert RF wire in crossing coronary in-stent chronic total occlusions in people with Coronary Artery Disease, run by Stereotaxis at 1 site in Netherlands.
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 16 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 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary RF wire success (time frame: Assessed and measured during interventional procedure up to discharge-average hospital stay 1-5 days- defined in protocol as the number of days between interventional treatment and hospital discharge). 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 20 Jul 2011.