Magnetic Navigation for Contrast and Radiation Reduction (MAGNA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Onze Lieve Vrouwe Gasthuis
Sponsor:
Information provided by (Responsible Party):
J.P.R. Herrman, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:
NCT01276808
First received: January 12, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention
Coronary Artery Disease
Procedure: Magnetic navigation PCI
Procedure: Conventional PCI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Reduction in Contrast Volume and Radiation With Magnetic Navigation: a Prospective Randomised Trial

Resource links provided by NLM:


Further study details as provided by Onze Lieve Vrouwe Gasthuis:

Primary Outcome Measures:
  • Total procedural contrast fluid use [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Short-term procedural success [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Procedure Fluoroscopy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Procedure time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Short term contrast nephropathy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • MACCE at 1 month and 12 months [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276808

Contacts
Contact: Mark S Patterson, PhD 020 5993440 dr.markspatterson@gmail.com

Locations
Netherlands
Onze Lieve Vrouwe Gasthuis Recruiting
Amsterdam, N Holland, Netherlands, 1091 AC
Contact: Mark S Patterson, PhD    020 5993440    dr.markspatterson@gmail.com   
Principal Investigator: Mark S Patterson, PhD         
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
Investigators
Principal Investigator: Mark S Patterson, PhD Onze Lieve Vrouwe Gasthuis
  More Information

No publications provided

Responsible Party: J.P.R. Herrman, MD PhD, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT01276808     History of Changes
Other Study ID Numbers: WO nummer R-10.420
Study First Received: January 12, 2011
Last Updated: August 19, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Onze Lieve Vrouwe Gasthuis:
Magnetic navigation, percutaneous coronary intervention

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

ClinicalTrials.gov processed this record on September 18, 2014