Magnetic Navigation for Contrast and Radiation Reduction (MAGNA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01276808
Recruitment Status : Unknown
Verified August 2014 by J.P.R. Herrman, Onze Lieve Vrouwe Gasthuis.
Recruitment status was:  Recruiting
First Posted : January 13, 2011
Last Update Posted : August 20, 2014
Information provided by (Responsible Party):
J.P.R. Herrman, Onze Lieve Vrouwe Gasthuis

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Magnetic navigation PCI Procedure: Conventional PCI Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reduction in Contrast Volume and Radiation With Magnetic Navigation: a Prospective Randomised Trial
Study Start Date : October 2011
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: Magnetic navigation PCI
These patients will be treated with magnetically navigated percutaneous coronary intervention
Procedure: Magnetic navigation PCI
Magnetically navigated angioplasty wire technique
Other Names:
  • coronary angioplasty
  • Percutaneous coronary intervention

Active Comparator: Conventional PCI
These patients will be treated with normal standard percutaneous coronary intervention
Procedure: Conventional PCI
Conventional manual angioplasty wire percutaneous coronary intervention
Other Names:
  • coronary angioplasty
  • Percutaneous coronary intervention

Primary Outcome Measures :
  1. Total procedural contrast fluid use [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Short-term procedural success [ Time Frame: 1 year ]
  2. Procedure Fluoroscopy [ Time Frame: 1 year ]
  3. Procedure time [ Time Frame: 1 year ]
  4. Short term contrast nephropathy [ Time Frame: 1 year ]
  5. MACCE at 1 month and 12 months [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 - 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01276808

Contact: Mark S Patterson, PhD 020 5993440

Onze Lieve Vrouwe Gasthuis Recruiting
Amsterdam, N Holland, Netherlands, 1091 AC
Contact: Mark S Patterson, PhD    020 5993440   
Principal Investigator: Mark S Patterson, PhD         
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
Principal Investigator: Mark S Patterson, PhD Onze Lieve Vrouwe Gasthuis

Responsible Party: J.P.R. Herrman, MD PhD, Onze Lieve Vrouwe Gasthuis Identifier: NCT01276808     History of Changes
Other Study ID Numbers: WO nummer R-10.420
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

Keywords provided by J.P.R. Herrman, Onze Lieve Vrouwe Gasthuis:
Magnetic navigation, percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases