Clinical Trial: Reperfusion of Pulmonary Arteriovenous Malformations After Embolotherapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Reperfusion of Pulmonary Arteriovenous Malformations After Embolotherapy. A Randomized Trial of Interlock™ Fibered IDC™ Occlusion System vs. Nester Coils

Brief Summary:

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.

Detailed Summary:

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 absc
Sponsor: St. Michael's Hospital, Toronto

Current Primary Outcome: Difference in reperfusion rate [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fluoroscopy/radiation time [ Time Frame: during procedure ]
    Fluoroscopy/radiation time
  • Contrast volume required [ Time Frame: during embolization ]
    Contrast volume required
  • Procedural time [ Time Frame: during embolization ]
    Procedural time
  • Complication rates [ Time Frame: during embolization ]
    Complication rates
  • Cost analysis [ Time Frame: during 10-14 months post procedure that is to final visit ]
    Cost analysis


Original Secondary Outcome: Same as current

Information By: St. Michael's Hospital, Toronto

Dates:
Date Received: May 15, 2013
Date Started: April 2013
Date Completion: April 2018
Last Updated: May 17, 2017
Last Verified: May 2017