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Reperfusion of Pulmonary Arteriovenous Malformations After Embolotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01856842
Recruitment Status : Active, not recruiting
First Posted : May 17, 2013
Last Update Posted : April 4, 2019
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arteriovenous Malformations Procedure: Angiography and embolotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reperfusion of Pulmonary Arteriovenous Malformations After Embolotherapy. A Randomized Trial of Interlock™ Fibered IDC™ Occlusion System vs. Nester Coils
Study Start Date : April 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Active Comparator: Interlock fibered IDC Occlusion System
Pulmonary angiography and embolotherapy technique using Interlock (TM) fibered IDC Occlusion System(TM)
Procedure: Angiography and embolotherapy
Active Comparator: Nestor Coil
Pulmonary angiography and embolotherapy technique using Nestor coils
Procedure: Angiography and embolotherapy

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Fluoroscopy/radiation time [ Time Frame: during procedure ]
    Fluoroscopy/radiation time

  2. Contrast volume required [ Time Frame: during embolization ]
    Contrast volume required

  3. Procedural time [ Time Frame: during embolization ]
    Procedural time

  4. Complication rates [ Time Frame: during embolization ]
    Complication rates

  5. Cost analysis [ Time Frame: during 10-14 months post procedure that is to final visit ]
    Cost analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients are eligible for inclusion in the study if all the following criteria are met:

  1. Documented presence of new (untreated) pulmonary AVMs requiring embolization
  2. Definite clinical diagnosis of HHT or genetic diagnosis of HHT
  3. Age ≥18 years
  4. Able to provide informed consent

Exclusion Criteria:

Patients will be excluded from the study if, in the opinion or knowledge of the Principal Investigator any of the following criterion is present:

  1. Participants with multiple AVMs within close proximity where identification of the aneurysm seen on CT cannot be precisely isolated for randomization purposes.
  2. Contra-indications to embolotherapy

    1. Severe chronic renal failure, without availability of dialysis
    2. Severe pulmonary hypertension (PA systolic estimated at >60mmHg)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01856842

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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
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Principal Investigator: Vikram Prabhudesai, MD St. Michael's Hospital, Toronto
Principal Investigator: Marie Faughnan, MD St. Michael's Hospital, Toronto
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Responsible Party: St. Michael's Hospital, Toronto Identifier: NCT01856842    
Other Study ID Numbers: 01-ANGIO-12
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by St. Michael's Hospital, Toronto:
Pulmonary Arteriovenous Malformations
Hereditary Hemorrhagic Telangiectasia (HHT)
reperfusion rates
Additional relevant MeSH terms:
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Arteriovenous Malformations
Arteriovenous Fistula
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Vascular Fistula
Pathological Conditions, Anatomical