Status:
COMPLETED
Reperfusion of Pulmonary Arteriovenous Malformations After Embolotherapy
Lead Sponsor:
Unity Health Toronto
Conditions:
Pulmonary Arteriovenous Malformations
Eligibility:
All Genders
18+ years
Phase:
NA
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 massi...
Detailed Description
Introduction Pulmonary arteriovenous malformations (AVMs) can lead to life-threatening complications. These complications can be prevented with pre-symptomatic embolization. The Interlock™ Fibered IDC...
Eligibility Criteria
Inclusion
- Patients are eligible for inclusion in the study if all the following criteria are met:
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01856842
Start Date
April 1 2013
End Date
December 1 2019
Last Update
October 22 2020
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8