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NCT05779787

COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)

COronary Re-EngageMent aFter RandOm NavitoR Alignment (COMFORT STUDY)
Niguarda Hospital·ClinicalTrials.gov·procedureRecruiting
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Study focus
Disease/Condition
Aortic Valve Stenosis,Transcatheter Aortic Valve Replacement
Drug/Device/Intervention
TAVR Aligned
Study type
Observational
Intervention type
procedure
Sponsor & location
Primary sponsor
Niguarda Hospital
Location
MIlano, Italy
Timeline & enrollment
Phase
N/A
Start date
Feb 15, 2023
End date
May 15, 2024
Enrollment
100 participants
Primary outcome

Coronary re-access after TAVR procedure

Summary

Whereas PCI before TAVR was previously recommended despite its uncertain prognostic role,
 recent data underline the possibility of a postponed coronary intervention using a
 commissural alignment technique. This approach allows easy coronary re-engagement through the
 valve stent frame with a trade off paid of procedure complexity.
 
 Considering the prevalence of coronary artery disease (CAD) and the increasing percentage of
 younger patients treated with TAVI, investigate whether a simpler procedure with random
 implantation of Navitor valve is not inferior in terms of coronary re-access, is required The
 key point of the project will be the evaluation of the feasibility of coronary re-engagement
 after a Navitor valve randomly implanted.

ICD-10 classifications
Aortic (valve) stenosisCongenital stenosis of aortic valveAortic (valve) stenosis with insufficiencyStenosis of aortaAortic valve disorder, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05779787
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05779787 through Pure Global AI's free database. This phase not specified trial is sponsored by Niguarda Hospital and is currently Recruiting. The study focuses on Aortic Valve Stenosis,Transcatheter Aortic Valve Replacement. Target enrollment is 100 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.