This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Reperfusion of Pulmonary Arteriovenous Malformations After Embolotherapy

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto Identifier:
First received: May 15, 2013
Last updated: May 17, 2017
Last verified: May 2017

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 Intervention
Pulmonary Arteriovenous Malformations Procedure: Angiography and embolotherapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01856842

Contact: Vikram Prabhudesai, MD 416 864 6060 ext 6702

Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Vikram Prabhudesai, MD         
Principal Investigator: Marie Faughnan, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Principal Investigator: Vikram Prabhudesai, MD St. Michael's Hospital, Toronto
Principal Investigator: Marie Faughnan, MD St. Michael's Hospital, Toronto
  More Information

Responsible Party: St. Michael's Hospital, Toronto Identifier: NCT01856842     History of Changes
Other Study ID Numbers: 01-ANGIO-12
Study First Received: May 15, 2013
Last Updated: May 17, 2017
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:
Congenital Abnormalities
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Arteriovenous Fistula
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Vascular Fistula
Pathological Conditions, Anatomical processed this record on September 21, 2017