Coronary Artery DiseaseMAGNANCT01276808
Magnetic Navigation for Contrast and Radiation Reduction
A study testing Magnetic navigation PCI and Conventional PCI in people with Coronary Artery Disease, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
Trial summary
Rationale: Magnetic navigation in complex lesions/vessels may result in reduced contrast and irradiation for patients undergoing percutaneous coronary intervention. The investigators aim to compare the use of the 2 techniques. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Magnetic navigation PCI and Conventional PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to Apr 2018
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age>18 years
- Elective presentation for PCI, This implies that the coronary anatomy is known and can be analysed according to the clinical prediction rule.(13)
- The included patients must have a calculated formula with a result equal or greater than 6.
- Pct=1Vb+1(Vl=1)+2(Vl=2)+2Vc+1Lbb)+1(Ll=1)+2(Ll=2)
- Pct - Predicted crossing time (prolonged if integer ≥ 6). Vb - Number of bends before the lesion. Each bend causes deformation of the wire resulting in friction. A greater number of bends leads to increased friction resulting in more difficultly in manipulating the wire.
- Vl - End-to-end length from the ostium to the lesion. The more distal the lesion is from the ostium, then the greater the chance of encountering problematic bends that impair manipulation, and also the longer the time required to physically pass the wire. This is divided into shorter than 50 mm (=0), between 50 and 100 mm (=1) and greater then 100 mm (=2).
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- Vc - Vessel calcification. Calcium may increase friction as the vessel becomes more rigid and less deformable and does not conform to the wire. The frictive effect of a specific angle will be accentuated if deformation cannot occur.
- Lbb - Side-branches within 10 mm. Side-branches within 10 mm of the lesion increase difficultly because, on the approach to a lesion finer control is necessary, the fixed wire-tip angle needed for bends now may have more of a predisposition for side-branches.
- Ll - Lesion length. Longer lesions produce more friction on the wire. The detailed analysis of 3D reconstruction by the Paeion system has been described earlier.(12) This rule was tested on a validation group taken from a second cohort of 415 lesions. The c-statistic derived from this group was 0.82 showing good discrimination.
- Patients can be admitted from the lounge, the ward or the CCU
- Diagnostic coronary angiography films suitable for 3D reconstruction Informed consent obtained.
Who cannot join
- Active bleeding
- Cardiogenic shock
- Resuscitation / intubation
- Cerebrovascular accident within 30 days
- Major bleeding within 30 days according to the TIMI definitions
- Severe hypertension (>180/110) after medical treatment
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- Relevant trauma or surgery within 6 weeks
- Active peptic ulcer within 3 months
- Hemorrhagic retinopathy
- Thrombocytopenia (<150)
- Severe renal dysfunction (Creatinine >140)
- Ongoing or desired use of GpIIb/IIIa blockers
- Participation in another clinical study
- Women who are pregnant or women who are breast-feeding. Inability to follow the patient (e.g. foreign or long-distance patients on holiday)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1091 AC
Mark S Patterson, PhD, 020 5993440, dr.markspatterson@gmail.com
Mark S Patterson, PhD
About this study
Official title: Reduction in Contrast Volume and Radiation With Magnetic Navigation: a Prospective Randomised Trial
Rationale: Magnetic navigation in complex lesions/vessels may result in reduced contrast and irradiation for patients undergoing percutaneous coronary intervention. The investigators aim to compare the use of the 2 techniques.
Objective: To compare the use of contrast and irradiation used in magnetically navigated PCI (MPCI) with conventional guidewire PCI (CPCI) in patients with complex anatomy (as defined by a clinical prediction rule).
Read more
Study design: Prospective randomised controlled, single-blind trial Study population: Healthy human volunteers aged 18 to 80 years of age Intervention (if applicable): One group has the placement of the angioplasty wire with magnetic navigation and the other has the angioplasty wire placed by conventional technique. All other interventions will be performed as per routine practice.
Main study parameters/endpoints:
Primary endpoint The primary endpoint is the amount of contrast used.
Secondary endpoints
- Contrast needed to cross a lesion
- procedural time
- radiation exposure
- Clinical complications at 1 and 12 months
- procedural success
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The index procedure is performed as per normal routine and includes history and examination. A blood test will be taken once vascular access has been obtained. After the procedure a questionnaire will be filled in. The patient will have a blood test 2 to 3 days after the procedure, telephone follow-up will occur at 1 and 6 months and a further outpatient visit with ECG will be planned for a year after the index procedure. No additional significant physical or psychological discomfort is expected with participation in the study.
Read the detailed description
The Stereotaxis Niobe® magnetic navigation system received regulatory approval for human clinical use for interventional cardiology in 2003.
Magnetic navigation gives 3 dimensional (3D) directional control over the guide-wire tip during percutaneous coronary intervention (PCI) procedures.
Magnetic navigation has been shown to be feasible and effective (1-3), case reports suggest that it enables the performance of procedures that could not be successfully finished conventionally (4-6), and that the use of the system may lead to reductions in contrast use and procedure time (7-11) that can be expected to result in better patient outcomes, and an economical advantage (less consumables per procedure, more procedures per session). There are only a few centers that perform magnetic navigation for percutaneous coronary intervention The OLVG has performed the most procedures of any of these centers and has included all the patients in a registry.
The registry at the OLVG suggests that different subgroups derive different benefit.
Distal lesions (10) defined as lesions more distal than the first 2 coronary segments from the aorta (thus RCA segment, mid LAD or distal Cx).
Technical success did not differ significantly between magnetic and conventional PCI (88.5 vs 96.2%; p=0.14). Significantly shorter procedural and fluoroscopy time were observed for magnetic compared to conventional PCI (29.9±17.1 vs 42.9±21.1 min, p<0.001; 8.2±7.7 vs 16.7±22.4 min, p=0.01 respectively). More contrast was used in de conventional PCI group (54 ml/patient; P=0.02). These advantages resulted in a mean saving of 1652 euro per patient (P<0.0001).
Primary PCI (11) The technical success rate was high in both the MPCI and CPCI groups (95.4% vs 98%; P = NS). There was significantly less contrast usage in the MPCI compared to the CPCI group (167±80/patient vs 220±87/patient; P<0.001). Procedural times were not significantly different for MPCI compared to CPCI (30.8±16.5 min vs 33.6±15.8 min, p=0.2) while fluoroscopy times were significantly better (8.1±5.0 min vs 14.6±26.5 min, p<0.05).
Simple lesions (8) as defined by the elective treatment of a single discrete stenosis that would require a maximum of two stents and excluding multiple lesions in the target vessel, multi-vessel PCI, bifurcation lesions, acute and chronic total occlusions, or a previous failed conventional attempt for the same target lesion.
Procedural and fluoroscopy times were not significantly different for MPCI compared to CPCI (21.0±14.5 min vs 24.7±14.0 min; 4.9±4.8 min vs 7.3±10.3 min, p=NS). There was a significant reduction in median contrast use (60 ml/patient [41-100] vs 100 ml/patient [64-130]; P=0.006).
Summary Benefit appears to increase depending on the complexity of the vessel/lesion with distal lesions showing a significant benefit in terms of contrast use, procedure time and fluoroscopy time.
Simple lesions show that procedures are not negatively influenced in terms of time, or irradiation and there may be benefit in terms of contrast use.
Acute procedures where time is at a premium (primary PCI for a heart attack) are not slowed by the use of the system.
Furthermore, the investigators have published a clinical prediction rule for selection of patients that will most benefit from this technology. (12)
The use of this system may have a number of benefits
- Reduction in the procedure time, irradiation and contrast use in the patient
- Better procedures with wire passage that maintains the tip coaxial in the vessel to avoid inadvertent sidebranch cannulation or more accurate bend/sidebranch entry to produce less complications
The hypothesis that MPCI is better than CPCI should be investigated by a randomized controlled trial (Magnetic navigation wire placement vs conventional wire placement).
The investigators plan to randomize patients into magnetic and conventional groups.
Endpoints:
- Primary endpoint Contrast use
- Secondary: Short-term procedural Procedure Fluoroscopy Procedure time Procedure success Short term contrast nephropathy
- Long-term MACCE at 1 month and 12 months.
- Conditions
- Coronary Artery Disease
- Being tested
- Magnetic navigation PCI, Conventional PCI
- Keywords
- Magnetic navigation, percutaneous coronary intervention
- 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.
Magnetic navigation PCIProcedure or surgery
Also called coronary angioplasty, Percutaneous coronary intervention
Magnetically navigated angioplasty wire technique
Conventional PCIProcedure or surgery
Also called coronary angioplasty, Percutaneous coronary intervention
Conventional manual angioplasty wire percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Magnetic navigation PCI | Experimental | These patients will be treated with magnetically navigated percutaneous coronary intervention Receives: Procedure: Magnetic navigation PCI |
| Conventional PCI | Active comparator | These patients will be treated with normal standard percutaneous coronary intervention Receives: Procedure: Conventional PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total procedural contrast fluid use
Measured: 1 year
Secondary outcomes (5)
Short-term procedural success
Measured: 1 year
Procedure Fluoroscopy
Measured: 1 year
Procedure time
Measured: 1 year
Short term contrast nephropathy
Measured: 1 year
MACCE at 1 month and 12 months
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2017 (estimated)
- Study completionApr 2018 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.P.R. Herrman, Onze Lieve Vrouwe Gasthuis
- Investigators
- Mark S Patterson, PhD, Principal investigator, Onze Lieve Vrouwe Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276808
- Sponsor's protocol ID
- WO nummer R-10.420
- Acronym
- MAGNA
- Status last verified
- Aug 2014
- First submitted
- 12 Jan 2011
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction in Contrast Volume and Radiation With Magnetic Navigation: a Prospective Randomised Trial
- ClinicalTrials.gov ID
- NCT01276808
- Acronym / sponsor ID
- MAGNA / WO nummer R-10.420
- Conditions
- Coronary Artery Disease
- Keywords
- Magnetic navigation, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 13 Jan 2011 (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.
Rationale: Magnetic navigation in complex lesions/vessels may result in reduced contrast and irradiation for patients undergoing percutaneous coronary intervention. The investigators aim to compare the use of the 2 techniques.
Objective: To compare the use of contrast and irradiation used in magnetically navigated PCI (MPCI) with conventional guidewire PCI (CPCI) in patients with complex anatomy (as defined by a clinical prediction rule).
Study design: Prospective randomised controlled, single-blind trial Study population: Healthy human volunteers aged 18 to 80 years of age Intervention (if applicable): One group has the placement of the angioplasty wire with magnetic navigation and the other has the angioplasty wire placed by conventional technique. All other interventions will be performed as per routine practice.
Main study parameters/endpoints:
Primary endpoint The primary endpoint is the amount of contrast used.
Secondary endpoints
- Contrast needed to cross a lesion
- procedural time
- radiation exposure
- Clinical complications at 1 and 12 months
- procedural success
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The index procedure is performed as per normal routine and includes history and examination. A blood test will be taken once vascular access has been obtained. After the procedure a questionnaire will be filled in. The patient will have a blood test 2 to 3 days after the procedure, telephone follow-up will occur at 1 and 6 months and a further outpatient visit with ECG will be planned for a year after the index procedure. No additional significant physical or psychological discomfort is expected with participation in the study.
Detailed description
The Stereotaxis Niobe® magnetic navigation system received regulatory approval for human clinical use for interventional cardiology in 2003.
Magnetic navigation gives 3 dimensional (3D) directional control over the guide-wire tip during percutaneous coronary intervention (PCI) procedures.
Magnetic navigation has been shown to be feasible and effective (1-3), case reports suggest that it enables the performance of procedures that could not be successfully finished conventionally (4-6), and that the use of the system may lead to reductions in contrast use and procedure time (7-11) that can be expected to result in better patient outcomes, and an economical advantage (less consumables per procedure, more procedures per session). There are only a few centers that perform magnetic navigation for percutaneous coronary intervention The OLVG has performed the most procedures of any of these centers and has included all the patients in a registry.
The registry at the OLVG suggests that different subgroups derive different benefit.
Distal lesions (10) defined as lesions more distal than the first 2 coronary segments from the aorta (thus RCA segment, mid LAD or distal Cx).
Technical success did not differ significantly between magnetic and conventional PCI (88.5 vs 96.2%; p=0.14). Significantly shorter procedural and fluoroscopy time were observed for magnetic compared to conventional PCI (29.9±17.1 vs 42.9±21.1 min, p<0.001; 8.2±7.7 vs 16.7±22.4 min, p=0.01 respectively). More contrast was used in de conventional PCI group (54 ml/patient; P=0.02). These advantages resulted in a mean saving of 1652 euro per patient (P<0.0001).
Primary PCI (11) The technical success rate was high in both the MPCI and CPCI groups (95.4% vs 98%; P = NS). There was significantly less contrast usage in the MPCI compared to the CPCI group (167±80/patient vs 220±87/patient; P<0.001). Procedural times were not significantly different for MPCI compared to CPCI (30.8±16.5 min vs 33.6±15.8 min, p=0.2) while fluoroscopy times were significantly better (8.1±5.0 min vs 14.6±26.5 min, p<0.05).
Simple lesions (8) as defined by the elective treatment of a single discrete stenosis that would require a maximum of two stents and excluding multiple lesions in the target vessel, multi-vessel PCI, bifurcation lesions, acute and chronic total occlusions, or a previous failed conventional attempt for the same target lesion.
Procedural and fluoroscopy times were not significantly different for MPCI compared to CPCI (21.0±14.5 min vs 24.7±14.0 min; 4.9±4.8 min vs 7.3±10.3 min, p=NS). There was a significant reduction in median contrast use (60 ml/patient [41-100] vs 100 ml/patient [64-130]; P=0.006).
Summary Benefit appears to increase depending on the complexity of the vessel/lesion with distal lesions showing a significant benefit in terms of contrast use, procedure time and fluoroscopy time.
Simple lesions show that procedures are not negatively influenced in terms of time, or irradiation and there may be benefit in terms of contrast use.
Acute procedures where time is at a premium (primary PCI for a heart attack) are not slowed by the use of the system.
Furthermore, the investigators have published a clinical prediction rule for selection of patients that will most benefit from this technology. (12)
The use of this system may have a number of benefits
- Reduction in the procedure time, irradiation and contrast use in the patient
- Better procedures with wire passage that maintains the tip coaxial in the vessel to avoid inadvertent sidebranch cannulation or more accurate bend/sidebranch entry to produce less complications
The hypothesis that MPCI is better than CPCI should be investigated by a randomized controlled trial (Magnetic navigation wire placement vs conventional wire placement).
The investigators plan to randomize patients into magnetic and conventional groups.
Endpoints:
- Primary endpoint Contrast use
- Secondary: Short-term procedural Procedure Fluoroscopy Procedure time Procedure success Short term contrast nephropathy
- Long-term MACCE at 1 month and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic navigation PCI | Experimental | Procedure: Magnetic navigation PCIThese patients will be treated with magnetically navigated percutaneous coronary intervention |
| Conventional PCI | Active comparator | Procedure: Conventional PCIThese patients will be treated with normal standard percutaneous coronary intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age>18 years
- Elective presentation for PCI, This implies that the coronary anatomy is known and can be analysed according to the clinical prediction rule.(13)
- The included patients must have a calculated formula with a result equal or greater than 6.
- Pct=1Vb+1(Vl=1)+2(Vl=2)+2Vc+1Lbb)+1(Ll=1)+2(Ll=2)
- Pct - Predicted crossing time (prolonged if integer ≥ 6). Vb - Number of bends before the lesion. Each bend causes deformation of the wire resulting in friction. A greater number of bends leads to increased friction resulting in more difficultly in manipulating the wire.
Key exclusion criteria (14 listed)
- Active bleeding
- Cardiogenic shock
- Resuscitation / intubation
- Cerebrovascular accident within 30 days
- Major bleeding within 30 days according to the TIMI definitions
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 navigation PCIAlso: coronary angioplasty, Percutaneous coronary interventionMagnetically navigated angioplasty wire technique | Procedure or surgery | Magnetic navigation PCI |
| Conventional PCIAlso: coronary angioplasty, Percutaneous coronary interventionConventional manual angioplasty wire percutaneous coronary intervention | Procedure or surgery | Conventional PCI |
Primary outcome
Total procedural contrast fluid use
Time frame: 1 year
5 secondary outcomes
Short-term procedural success
Time frame: 1 year
Procedure Fluoroscopy
Time frame: 1 year
Procedure time
Time frame: 1 year
Short term contrast nephropathy
Time frame: 1 year
MACCE at 1 month and 12 months
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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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.
Mark S Patterson, PhD principal investigator
Onze Lieve Vrouwe Gasthuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic navigation PCI and Conventional PCI in people with Coronary Artery Disease, run by Onze Lieve Vrouwe Gasthuis 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 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 20 Aug 2014. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark S Patterson, PhD (020 5993440, dr.markspatterson@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total procedural contrast fluid use (time frame: 1 year). 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 Aug 2014.