Reperfusion of Pulmonary Arteriovenous Malformations After Embolotherapy. A Randomized Trial of Interlock™ Fibered IDC™ Occlusion System vs. Nester Coils
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Difference in reperfusion rate
研究概览
简要总结
AVMs are abnormal collections of blood vessels which can occur in any part of the body including the lungs. These blood vessels are weakened and can rupture anytime causing bleeding which can be massive, leading to life-threatening conditions.
Pulmonary AVMs occur in about 40% of patients with HHT. Each patient may have an average of 5 AVMs .Rupture of the AVM can lead to massive bleeding in the lung, stroke and infection of the brain. In order to prevent these complications, patients with HHT are routinely examined for pulmonary AVMs and treatment with embolization is recommended.
AVMs have a main blood vessel or artery supplying blood to the collection of blood vessels. The way to treat AVMs is cut off their blood supply through a process called embolization.
Embolization is a standard medical procedure which is done to stop or prevent hemorrhage (bleeding) from an AVM. It involves blocking the artery that supplies blood to the AVM by inserting a foreign body, into the blood vessel supplying blood to the AVM.
Standard devices used for embolization include coils (made of stainless steel or platinum). These devices usually have a good success rate for blocking the artery that supplies blood to the AVM. However, a few AVMs that are embolized by standard devices may reopen over time. This is called reperfusion and will require repeat embolization procedures.
For embolization of pulmonary AVMs at St. Michael's Hospital, the Nester coil is used. In this study, we would like to compare the Nester coil with a new coil device called the Interlock Fibered IDC Occlusion System. Both coils are approved for use in Canada, however the cost of the IDC coil limits its use at this hospital.
Compared to the Nester coil, the IDC coils are made so that they can be removed or repositioned if they are not placed correctly. The coil also allows tighter packing which helps prevent reperfusion.
This study will compare the success rate of embolization between the Interlock™ Fibered IDC™ Occlusion System (IDC coil) and the Nester coil.
详细描述
Introduction Pulmonary arteriovenous malformations (AVMs) can lead to life-threatening complications. These complications can be prevented with pre-symptomatic embolization. The Interlock™ Fibered IDC™ Occlusion System coil (IDC) is a new device which might be more effective for embolizing pulmonary AVMs. This study will investigate the efficacy of the Interlock™ Fibered IDC™ Occlusion System and compare rates of reperfusion using Nestor coils (standard coils used at participating centre) versus Interlock™ Fibered IDC™ Occlusion, randomizing by AVM.
Rationale Reperfused AVMs put the patient at risk of pulmonary AVM complications. As such, these AVMs require repeat embolotherapy and therefore patients are subjected to further radiation, contrast and hospitalization. A number of devices have been studied and are currently being used for embolization of pulmonary AVMs including coils (stainless steel, platinum) and plugs (Amplatzer plugs). The immediate technical success rate is nearly 100%, but long-term reperfusion occurrence is approximately 15% of treated AVMs and up to 30% of patients. The IDC coil characteristics may lead to reduced reperfusion rates. No studies of IDC coils have been reported to date in the management of pulmonary AVMs. Safety of IDC coils has been demonstrated in other organs. Embolization procedure with IDC coils is similar to embolization with other devices, in terms of fluoroscopy time use and contrast load, as are procedural complication rates.
Background Pulmonary AVMs are present in approximately 40% of patients with hereditary hemorrhagic telangiectasia (HHT), with a mean of five pulmonary AVMs per patient. Pulmonary AVMs can lead to life-threatening and debilitating complications, such as massive haemoptysis, spontaneous haemothorax, stroke and cerebral abscess. Fortunately, these complications are preventable, through screening of HHT patients and preventative treatment of pulmonary AVMs, as summarized in a recent decision analysis. The International HHT Guidelines recommends routine screening of all HHT patients for pulmonary AVMs, with preventative transcatheter embolotherapy of all significant pulmonary AVMs.
Most published data have reported outcomes with stainless steel or platinum coils, and fewer with detachable balloons or Amplatzer plugs. Even with good success rates, reperfusion has generally been reported in the range of 15% of embolized AVMs with routine embolization using stainless steel or platinum coils. To date, comparative studies between stainless steel and platinum coils have not shown significant differences in outcomes.
PLAN OF INVESTIGATION Study Hypothesis The device of interest has local characteristics including better positioning and controlled release, together with tighter packing, which may lead to superior outcomes and reduce costs as well as radiation time. Therefore it is hypothesized that the IDC coil will be associated with less reperfusion than standard Nestor coils, and will present a therapeutic advantage over Nestor coils.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible for inclusion in the study if all the following criteria are met:
- •Documented presence of new (untreated) pulmonary AVMs requiring embolization
- •Definite clinical diagnosis of HHT or genetic diagnosis of HHT
- •Age ≥18 years
- •Able to provide informed consent
排除标准
- •Patients will be excluded from the study if, in the opinion or knowledge of the Principal Investigator any of the following criterion is present:
- •Participants with multiple AVMs within close proximity where identification of the aneurysm seen on CT cannot be precisely isolated for randomization purposes.
- •Contra-indications to embolotherapy
- •Severe chronic renal failure, without availability of dialysis
- •Severe pulmonary hypertension (PA systolic estimated at >60mmHg)
结局指标
主要结局
Difference in reperfusion rate
时间窗: 10-14 months post embolization
The primary end-point for this study is the difference in reperfusion rate between the two treatment groups from procedure day to the final follow-up at 10-14 month post embolization, measured by the unenhanced CT Chest.
次要结局
- Fluoroscopy/radiation time(during procedure)
- Procedural time(during embolization)
- Complication rates(during embolization)
- Cost analysis(during 10-14 months post procedure that is to final visit)
- Contrast volume required(during embolization)