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