Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-29 @ 11:03 AM
Study NCT ID:
NCT07195968
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-29
First Post:
2025-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analysis of NTG-Pd/Pa and Saline-Pd/Pa (CANS)
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
A Prospective, Multicenter Study: Comparative Analysis of NTG-Pd/Pa and Saline-Pd/Pa
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-09
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:
None
Brief Summary:
The goal of this observational study is to compare the value of NTG-Pd/Pa and saline-Pd/Pa in participants with intermediate stenosis of the coronary artery. The main questions it aims to answer are:
The numerical difference between NTG-Pd/Pa and saline-Pd/Pa To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment?
Participants will undergo NTG-Pd/Pa, Saline-Pd/Pa, and FFR successively in the target vessel.
The numerical difference between NTG-Pd/Pa and saline-Pd/Pa To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment?
Participants will undergo NTG-Pd/Pa, Saline-Pd/Pa, and FFR successively in the target vessel.
Detailed Description:
Fractional Flow Reserve (FFR) is the gold standard for determining the functional ischemia of coronary arteries with intermediate lesions. Both intracoronary nitroglycerine (NTG) administration and saline administration induce an acute drop in trans-lesional coronary pressure. Both pressure ratios correlate well with FFR values and can reliably predict positive results in FFR assessments. The aims of this study were
1. To evaluate the numerical difference between NTG-Pd/Pa and saline-Pd/Pa.
2. To test the repeatability of saline-Pd/Pa.
3. To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment.
Participants will be enrolled prospectively from National Taiwan University Hospital Hsinchu Hospital, Miaoli General Hospital, and Taichung Veterans General Hospital. The coronary artery with intermediate stenosis will undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments sequentially. Saline-Pd/Pa will be tested repeatedly during the assessment.
1. To evaluate the numerical difference between NTG-Pd/Pa and saline-Pd/Pa.
2. To test the repeatability of saline-Pd/Pa.
3. To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment.
Participants will be enrolled prospectively from National Taiwan University Hospital Hsinchu Hospital, Miaoli General Hospital, and Taichung Veterans General Hospital. The coronary artery with intermediate stenosis will undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments sequentially. Saline-Pd/Pa will be tested repeatedly during the assessment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: