Magnetic Navigation for Contrast and Radiation Reduction (MAGNA)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Magnetic navigation, percutaneous coronary intervention
Eligibility Criteria
Inclusion Criteria:
- 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=1*Vb+1*(Vl=1)+2*(Vl=2)+2*Vc+1*Lbb)+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).
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.
Exclusion Criteria:
- 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
- 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)
Sites / Locations
- Onze Lieve Vrouwe GasthuisRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Magnetic navigation PCI
Conventional PCI
These patients will be treated with magnetically navigated percutaneous coronary intervention
These patients will be treated with normal standard percutaneous coronary intervention