Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:29 AM
Study NCT ID:
NCT07417150
Status:
RECRUITING
Last Update Posted:
2026-02-18
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAlcified Coronary Lesions Identification & Quantification With X Rays
Sponsor:
RCF@ICPS
Organization:
Study Overview
Official Title:
CAlcified Coronary Lesions Identification & Quantification With X Rays
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALIQX
Brief Summary:
The CALIQX trial is a prospective, multicenter, non-randomized pilot study comparing the 3DStent and IVUS methods for quantifying native coronary calcifications. The trial falls under classification 4.3 according to the classification and evaluation process under EU Regulation 2017/745 (MDR) and national adaptation of clinical investigations concerning medical devices: CE-marked medical device (any class), used off-label without the objective of CE marking or establishing conformity.
Compare the evaluation of native coronary calcifications with 3D Stent tool versus evaluation by intracoronary IVUS imaging.
Compare the evaluation of native coronary calcifications with 3D Stent tool versus evaluation by intracoronary IVUS imaging.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: