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. 2018 Jan 4;2018(1):CD008017. doi: 10.1002/14651858.CD008017.pub5

NCT01856842.

Trial name or title Reperfusion of Pulmonary Arteriovenous Malformations After Embolotherapy. A Randomized Trial of Interlock™ Fibered IDC™ Occlusion System vs. Nester Coils
Methods Single‐centre randomised controlled trial in Toronto, Canada.
Single blind (participant)
Participants Inclusion criteria:
‐ 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 criteria:
‐ 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 including severe chronic renal failure, without availability of dialysis. Severe pulmonary hypertension (PA systolic estimated at >60mmHg)
Interventions This study will compare the success rate of embolization between the Interlock™ Fibered IDC™ Occlusion System (IDC coil) and the Nester coil.
Outcomes Primary outcome measure
‐ difference in reperfusion rate between the 2 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
‐ contrast volume required
 ‐ procedural time
 ‐ complication rates
 ‐ cost analysis
Starting date March 2014 ‐ currently recruiting participants
Contact information Vikram Prabhudesai, MD. prabhudesaiv@smh.ca
Notes https://clinicaltrials.gov/ct2/show/NCT01856842?term=pulmonary+arteriovenous+malformation&rank=1

AVMs: arterial malformations
 CT: computer tomography
 HHT: hereditary haemorrhagic telangiectasia