NCT Number: NCT05682118
In patients with 50-90% stenosis of the coronary artery, the coronary roadmap (dynamic roadmap) is performed when the conventional fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are performed. coronary roadmap system) to confirm the effectiveness of the function.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Not applicable
Yongin, Gyeonggi-do, 16995, South Korea
Location status: Recruiting
Deok-Kyu Cho, MD
SUB_INVESTIGATOR
Eui Im, MD
SUB_INVESTIGATOR
Ji Woong Roh, MD, PhD
SUB_INVESTIGATOR
Oh-Hyun Lee, MD
SUB_INVESTIGATOR
Yongcheol Kim, MD
CONTACT
Yongcheol Kim, MD, PhD
PRINCIPAL_INVESTIGATOR
In coronary angiography, 50% or more stenosis of the causative vessel is observed in a patient with stable angina pectoris (SAP) or 50% or more stenosis of a non-causative vessel is observed in acute coronary syndrome (ACS) Based on 0.90, if it is less than 0.89, PCI is performed, and if it is 0.90 or more, drug treatment is performed. When the pressure wire tests are performed, the pressure wire is inserted from the origin of the blood vessel through the lesion to the distal portion, and the pressure wire is placed at the distal end of the blood vessel for measurement. In this process, there are many cases where the pressure wire escapes the branch blood vessel or does not pass through well. It takes a long time to stand up and evaluate stenosis, and in many cases, an additional contrast medium is used to additionally check blood vessel travel and to check the position and condition of the pressure wire. To overcome this, the software roadmap installed in the cardiac fluoroscopy device of the cardiac catheterization room can be helpful. However, there are currently no studies related to roadmaps in coronary artery examination. Therefore, in this study, we want to evaluate the effectiveness of the roadmap when examining FFR and iFR.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FFR and iFR tests using the roadmap system, or FFR and iFR tests without using the roadmap system.
Pressure wire into guiding catheter The equalization of the pressure wire with the aortic pressure(after placing the pressure wire on the tip of the guiding catheter and removal of contrast media by saline flushing) and the placement of the pressure wire on the distal of the blood vessel to measure iFR. After iFR measurement, the pressure wire was pulled back into the tip of the guiding catheter to check the presence of pressure drift. A final Pd/Pa between 0.97 and 1.03 is considered acceptable. Following confirming no pressure drift, a mode change will be done from iFR to FFR, and then a re-check of the time between the equalization of the pressure wire with the aortic pressure will be planned. In all lesions, FFR value were measured with hyperemia, achieved by intracoronary (IC) bolus injection of nicorandil (Sigmart®; Chugai Pharmaceutical Co., Ltd., Tokyo, Japan) 2 mg.
Patients undergoing pressure wire test with moderate stenosis. Pressure wire into guiding catheter The equalization of the pressure wire with the aortic pressure(after placing the pressure wire on the tip of the guiding catheter and removal of contrast media by saline flushing) and the placement of the pressure wire on the distal of the blood vessel to measure iFR. After iFR measurement, the pressure wire was pulled back into the tip of the guiding catheter to check the presence of pressure drift. A final Pd/Pa between 0.97 and 1.03 is considered acceptable. Following confirming no pressure drift, a mode change will be done from iFR to FFR, and then a re-check of the time between the equalization of the pressure wire with the aortic pressure will be planned. In all lesions, FFR value were measured with hyperemia, achieved by intracoronary (IC) bolus injection of nicorandil (Sigmart®; Chugai Pharmaceutical Co., Ltd., Tokyo, Japan) 2 mg.
Time frame: Through procedure completion, up to 24 hours
iFR time: the time interval between the pressure wire into the guiding catheter and the placement of the pressure wire on the distal of the blood vessel to measure iFR
Time frame: Through procedure completion, up to 24 hours
FFR time: the time interval between the equalization of the pressure wire for FFR and the placement of the pressure wire on the distal of the blood vessel to measure FFR
Time frame: Through procedure completion, up to 24 hours
The success rate of advancing pressure wire to a target vessel distally
Time frame: Through procedure completion, up to 24 hours
Use of contrast medium until the pressure wire is advanced to the distal end of the blood vessel
Time frame: Through procedure completion, up to 24 hours
The amount of contrast medium used until the pressure wire is advanced to the distal end of the blood vessel
Time frame: Through procedure completion, up to 24 hours
Total procedure time between insertion and out of guiding catheter via a sheath
Time frame: Through procedure completion, up to 24 hours
Total procedure time
Time frame: Through procedure completion, up to 24 hours
Total amount of contrast media usage
Time frame: Through procedure completion, up to 24 hours
Total dose of radiation exposure
Time frame: Through procedure completion, up to 24 hours
Complications related to the procedure
Contact information is provided by the study sponsor or research team.
Ji Woong Roh, MD, PhD
CONTACT
Yongcheol Kim, MD, PhD
CONTACT
Yonsei University
Other
Impact of Dynamic CoROnary RoADmap System for Guidance of Instantaneous Wave-Free Ratio or Fractional Flow Reserve: A Single-Center, Randomized Study (ROAD-IFR Trial)
Acronym: ROAD-IFR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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