Reperfusion of Pulmonary Arteriovenous Malformations After Embolotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by St. Michael's Hospital, Toronto
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01856842
First received: May 15, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Fluoroscopy/radiation time

  • Contrast volume required [ Time Frame: during embolization ] [ Designated as safety issue: No ]
    Contrast volume required

  • Procedural time [ Time Frame: during embolization ] [ Designated as safety issue: No ]
    Procedural time

  • Complication rates [ Time Frame: during embolization ] [ Designated as safety issue: No ]
    Complication rates

  • Cost analysis [ Time Frame: during 10-14 months post procedure that is to final visit ] [ Designated as safety issue: No ]
    Cost analysis


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Primary Completion Date: April 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01856842

Contacts
Contact: Vikram Prabhudesai, MD 416 864 6060 ext 6702 prabhudesaiv@smh.ca
Contact: Camalene Chrysostoum, BSc, CCRA 416 864 6060 ext 77194 chrysostoumc@smh.ca

Locations
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
Investigators
Principal Investigator: Vikram Prabhudesai, MD St. Michael's Hospital, Toronto
Principal Investigator: Marie Faughnan, MD St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01856842     History of Changes
Other Study ID Numbers: 01-ANGIO-12
Study First Received: May 15, 2013
Last Updated: March 12, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Pulmonary Arteriovenous Malformations
Hereditary Hemorrhagic Telangiectasia (HHT)
Embolization
reperfusion rates

Additional relevant MeSH terms:
Arteriovenous Malformations
Congenital Abnormalities
Hemangioma
Arteriovenous Fistula
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Vascular Fistula
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014