Magnetic Navigation for Contrast and Radiation Reduction

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2011
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.
Epistemonikos ID: 2c7dc7d2c0b39607c04543ecc66947e56bee806d
First added on: May 06, 2024