臨床研究等提出・公開システム

Date of registration	Jan. 30, 2026
Last modified on	Jan. 30, 2026
Trial ID	jRCT1050250212

Scientific Title	Study on the Feasibility of Coronary Access after Evolut FX+ Implantation
Public Title	Feasibility of Coronary Access after Evolut FX+

Contact for Scientific Queries	Name	Maeda Koichi
	Affiliation	The University of Osaka
	Address	2-2, Yamadaoka, Suita, Osaka, Japan
	Telephone	+81-6-6879-3154
	E-mail	maeda.kouichi.med@osaka-u.ac.jp
Contact for Public Queries	Name	Maeda Koichi
	Affiliation	The University of Osaka
	Address	2-2, Yamadaoka, Suita, Osaka, Japan
	Telephone	+81-6-6879-3154
	E-mail	maeda.kouichi.med@osaka-u.ac.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		Oct. 20, 2025
Actual date of first enrollment		Oct. 20, 2025
Target sample size		250
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	i: The study will include 100 patients who underwent TAVI using Evolut FX+ after June 1, 2025, and for whom CT scans were performed. ii: It will also include 150 patients who underwent TAVI using Evolut FX before May 31, 2025, and for whom CT scans were performed. For patients who underwent TAVI with Evolut FX, the study will include 150 consecutive cases among patients treated at the research institution who underwent CT imaging before May 31.
	Exclusion Criteria	creatinine clearance less than 30 mL/min prosthetic valve dysfunction bicuspid or unicuspid valves for whom the procedure was unsuccessful contrast agent allergy When a proxy is required for any reason When a subject refuses to participate in or continue the study
	Age Minimum	No limit
	Age Maximum	No limit

Health Condition(s) or Problem(s) Studied		aortic stenosis
Primary Outcome(s)		For postoperative evaluation purposes, coronary artery access ease during contrast-enhanced CT is classified into three levels based on the positional relationship between the coronary artery and the window, as follows. The distribution is assessed using Fisher's exact test or chi-square test. Favorable The coronary artery opening is located anterior to a large window. Intermediate The coronary artery opening is located anterior to a small (normal) window. Unfavorable The coronary artery opening is located at the THV junction post or anterior to the skirt.
Secondary Outcome(s)		Secondary endpoints: Valve function (mean pressure gradient, valve orifice area, degree of annular regurgitation); Perioperative outcomes (mortality rate, major cardiovascular adverse events and cerebrovascular adverse events, reoperation rate) Note: For the above endpoints, propensity score adjustment will be performed to account for and adjust for differences in baseline characteristics between device groups.

Primary Sponsor	NA

Secondary Sponsor

Secondary Sponsor	Not applicable

Name of Certified Review Board	the Ethics Committee of the University of Osaka
Address	2-2 Yamadaoka, Suita, Osaka, Osaka
Telephone	+81-6-6210-8296
E-Mail	rinri@hp-crc.med.osaka-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 17, 2025

Countries of Recruitment（Except Japan）	none