Magnetic Navigation for Contrast and Radiation Reduction (MAGNA)
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|ClinicalTrials.gov 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
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.
- 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.
|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|
|Intervention Model:||Single Group Assignment|
|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|
Experimental: Magnetic navigation PCI
These patients will be treated with magnetically navigated percutaneous coronary intervention
Procedure: Magnetic navigation PCI
Magnetically navigated angioplasty wire technique
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
- Total procedural contrast fluid use [ Time Frame: 1 year ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01276808
|Contact: Mark S Patterson, PhD||020 firstname.lastname@example.org|
|Onze Lieve Vrouwe Gasthuis||Recruiting|
|Amsterdam, N Holland, Netherlands, 1091 AC|
|Contact: Mark S Patterson, PhD 020 5993440 email@example.com|
|Principal Investigator: Mark S Patterson, PhD|
|Principal Investigator:||Mark S Patterson, PhD||Onze Lieve Vrouwe Gasthuis|