Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cereb⦠(NCT05145283) | Clinical Trial Compass
CompletedPhase 2
Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation
Switzerland141 participantsStarted 2022-03-16
Plain-language summary
The aim of this trial is to assess the safety and efficacy of conestat alfa (RuconestĀ®, Pharming Technologies B.V.) on renal and cerebral ischemic events in patients undergoing TAVI for severe symptomatic aortic stenosis (AS) compared to placebo.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed consent as documented by signature
* Severe AS and scheduled for transfemoral TAVI
Exclusion Criteria:
* Contraindications to the class of drugs under study (C1INH), e.g., known hypersensitivity or allergy to class of drugs or the investigational product
* History of allergy to rabbits (as rhC1INH is derived from the breast milk of transgenic rabbits)
* Women who are pregnant or breast feeding
* Hemodynamic instability requiring emergency TAVI
* Valve-in-valve procedure
* Other access route than transfemoral
* Non-cardiac co-morbidity with expected survival \<6 months
* Ischemic or hemorrhagic stroke within 30 days before TAVI
* Dialysis or estimated glomerular filtration rate (eGFR) \<20 ml/min/1.73m2
* Contraindication for MRI such as a permanent non-MRI compatible pacemaker or severe claustrophobia
* Liver cirrhosis (any Child-Pugh score)
* Incapacity or inability to provide informed consent
* Participation in another study with investigational drug or medical device within the 30 days preceding and during the present study
* Previous enrolment into the current study
* Any uncontrolled or significant concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements at the discretion of the investigator
What they're measuring
1
Total volume of new cerebral ischemic lesions as evaluated by magnetic resonance imaging (MRI)
Timeframe: on day 4 (+/-1 day) after transfemoral TAVI