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Magnetic Navigation for Contrast and Radiation Reduction

NCT01276808 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-08-20

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Magnetic navigation PCI

Magnetically navigated angioplasty wire technique

PROCEDURE

Conventional PCI

Conventional manual angioplasty wire percutaneous coronary intervention

Sponsors & Collaborators

  • Onze Lieve Vrouwe Gasthuis

    lead OTHER

Principal Investigators

  • Mark S Patterson, PhD · Onze Lieve Vrouwe Gasthuis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2017-04-30
Completion
2018-04-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01276808 on ClinicalTrials.gov