NCT05145283CompletedPhase 2
Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation
Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation: a Multi-center, Randomized, Double-blind, Placebo-controlled Investigational Study (PAIR-TAVI).
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
The aim of this trial is to assess the safety and efficacy of conestat alfa (Ruconest®, Pharming Technologies B.V.) on renal and cerebral ischemic events in patients undergoing TAVI for severe symptomatic aortic stenosis (AS) compared to placebo.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 141 (actual)
- First submitted
- 17 Nov 2021
- Start date
- 16 Mar 2022
- Primary completion date
- 5 Jan 2026
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Stroke
- NCT number
- NCT05145283
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 141
- From 16 Mar 2022 to the primary completion date, 5 Jan 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to the class of drugs under study (C1INH), e.g., known hypersensitivity or allergy to class of drugs or the investigational product
- Ischemic or hemorrhagic stroke within 30 days before TAVI
- 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
Other illness
- History of allergy to rabbits (as rhC1INH is derived from the breast milk of transgenic rabbits)
- Non-cardiac co-morbidity with expected survival \<6 months
Lab values
- Dialysis or estimated glomerular filtration rate (eGFR) \<20 ml/min/1.73m2
Other
- Women who are pregnant or breast feeding
- Hemodynamic instability requiring emergency TAVI
- Valve-in-valve procedure
- Other access route than transfemoral
- 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
Who the study is looking for
- Informed consent as documented by signature
- Severe AS and scheduled for transfemoral TAVI
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Basel, Division of Internal Medicine Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Stadtspital Triemli Zürich, Division of Cardiology Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.