Reduction in Contrast Volume and Radiation With Magnetic Navigation: a Prospective Randomised Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Total procedural contrast fluid use
研究概览
简要总结
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
- 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.
详细描述
The Stereotaxis Niobe® magnetic navigation system received regulatory approval for human clinical use for interventional cardiology in 2003.
Magnetic navigation gives 3 dimensional (3D) directional control over the guide-wire tip during percutaneous coronary intervention (PCI) procedures.
Magnetic navigation has been shown to be feasible and effective (1-3), case reports suggest that it enables the performance of procedures that could not be successfully finished conventionally (4-6), and that the use of the system may lead to reductions in contrast use and procedure time (7-11) that can be expected to result in better patient outcomes, and an economical advantage (less consumables per procedure, more procedures per session). There are only a few centers that perform magnetic navigation for percutaneous coronary intervention The OLVG has performed the most procedures of any of these centers and has included all the patients in a registry.
The registry at the OLVG suggests that different subgroups derive different benefit.
Distal lesions (10) defined as lesions more distal than the first 2 coronary segments from the aorta (thus RCA segment, mid LAD or distal Cx).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- •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)
结局指标
主要结局
Total procedural contrast fluid use
时间窗: 1 year
次要结局
- Procedure Fluoroscopy(1 year)
- Procedure time(1 year)
- Short term contrast nephropathy(1 year)
- Short-term procedural success(1 year)
- MACCE at 1 month and 12 months(2 years)
研究者
J.P.R. Herrman
MD PhD
Onze Lieve Vrouwe Gasthuis