Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tested using the roadmap system | Experimental | tested using the roadmap system |
|
| tested without using the roadmap system | Active Comparator | tested without using the roadmap system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| roadmap | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| iFR time | 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 | Through procedure completion, up to 24 hours |
| FFR time | 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 | Through procedure completion, up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of placement of the pressure wire on the distal of the blood vessel to measure iFR/FFR | The success rate of advancing pressure wire to a target vessel distally | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongcheol Kim, MD, PhD | Contact | +823151898967 | yongcheol@yuhs.ac | |
| Ji Woong Roh, MD, PhD | Contact | +823151898792 | NOMGALDA@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Yongcheol Kim, MD, PhD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongcheol Kim | Recruiting | Yongin | Gyeonggi-do | 16995 | South Korea |
The data set is available from the the corresponding author upon reasonable request.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
The sample size was calculated using effect size (Cohen's d) for the effectiveness of the dynamic coronary roadmap system for the guidance of the iFR and FFR. The effect size was assumed to be 0.4, which is a small to medium effect size. The sample size of 113 participants for each group was estimated to provide 90% power with a 2-sided type I error of 0.05.
This is a single-center randomized study and will be conducted in 226 patients with 50-90% coronary artery stenosis on angiography. Afterward, randomly assigned, 113 patients will be tested using the roadmap system, and 113 patients will be tested without using the roadmap system. Methods for measuring FFR and iFR and all PCI will use standardized testing and procedure methods.
Not provided
Not provided
Not provided
Not provided
|
| iFR/FFR | Procedure | 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. |
|
Use of contrast medium until the pressure wire is advanced to the distal end of the blood vessel |
| 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 | The amount of contrast medium used until the pressure wire is advanced to the distal end of the blood vessel | Through procedure completion, up to 24 hours |
| Total procedure time to assess functional significance using iFR/FFR pressure wire | Total procedure time between insertion and out of guiding catheter via a sheath | Through procedure completion, up to 24 hours |
| Total procedure time | Total procedure time | Through procedure completion, up to 24 hours |
| Total amount of contrast media usage | Total amount of contrast media usage | Through procedure completion, up to 24 hours |
| Total dose of radiation exposure | Total dose of radiation exposure | Through procedure completion, up to 24 hours |
| Complications related to the procedure | Complications related to the procedure | Through procedure completion, up to 24 hours |