Reperfusion of Pulmonary Arteriovenous Malformations After Embolotherapy

NCT01856842 | Completed

• 1 other identifier: 01-ANGIO-12
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arteriovenous Malformations

Keywords

Pulmonary Arteriovenous Malformations; Hereditary Hemorrhagic Telangiectasia (HHT); Embolization; reperfusion rates

Outcome Measures

Primary Outcomes (1)

• Difference in reperfusion rate

  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.

  10-14 months post embolization

Secondary Outcomes (5)

• Fluoroscopy/radiation time

  during procedure

• Contrast volume required

  during embolization

• Procedural time

  during embolization

• Complication rates

  during embolization

• Cost analysis

  during 10-14 months post procedure that is to final visit

Study Arms (2)

Interlock fibered IDC Occlusion System

ACTIVE COMPARATOR

Pulmonary angiography and embolotherapy technique using Interlock (TM) fibered IDC Occlusion System(TM)

Procedure: Angiography and embolotherapy

Nestor Coil

ACTIVE COMPARATOR

Pulmonary angiography and embolotherapy technique using Nestor coils

Procedure: Angiography and embolotherapy

Interventions

Angiography and embolotherapy PROCEDURE

Interlock fibered IDC Occlusion System; Nestor Coil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

• Kennedy SA, Faughnan ME, Vozoris NT, Prabhudesai V. Reperfusion of Pulmonary Arteriovenous Malformations Following Embolotherapy: A Randomized Controlled Trial of Detachable Versus Pushable Coils. Cardiovasc Intervent Radiol. 2020 Jun;43(6):904-909. doi: 10.1007/s00270-020-02422-8. Epub 2020 Feb 4.

  PMID: 32020296 RESULT

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Vikram Prabhudesai, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Marie Faughnan, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 17, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)