NCT01276808

Magnetic Navigation for Contrast and Radiation Reduction

Reduction in Contrast Volume and Radiation With Magnetic Navigation: a Prospective Randomised Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Onze Lieve Vrouwe Gasthuis · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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. 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 1. Contrast needed to cross a lesion 2. procedural time 3. radiation exposure 4. Clinical complications at 1 and 12 months 5. 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 1. Reduction in the procedure time, irradiation and contrast use in the patient 2. 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: 1. Primary endpoint Contrast use 2. Secondary: Short-term procedural Procedure Fluoroscopy Procedure time Procedure success Short term contrast nephropathy 3. Long-term MACCE at 1 month and 12 months.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Magnetic navigation PCI	Magnetically navigated angioplasty wire technique
PROCEDURE	Conventional PCI	Conventional manual angioplasty wire percutaneous coronary intervention

Timeline

• Start date: 2011-10-01
• Primary completion: 2017-04-01
• Completion: 2018-04-01
• First posted: 2011-01-13
• Last updated: 2014-08-20

Locations

1 site across 1 country: Netherlands