Ignite Creation Date:
2024-05-06 @ 2:19 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04284345
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2020-01-09
Brief Title:
Saline-induced Distal to Aortic Coronary Pressure Ratio vs Resting and Hyperemic Indices of Coronary Artery Stenosis Severity
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Diagnostic Accuracy of the Saline-induced Distal to Aortic Coronary Pressure Ratio Compared With Clinically Available Resting and Hyperemic Indices of Coronary Artery Stenosis Severity
Status:
COMPLETED
Status Verified Date:
2024-05
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:
SALINE
Brief Summary:
The presence of inducible myocardial ischemia is considered as the prerequisite for the clinical benefit of coronary revascularization In this regard the introduction of invasive pressure-derived physiological indices to guide myocardial revascularization represented a major breakthrough for the treatment of patients with coronary artery disease CAD by moving the focus of coronary revascularization from anatomy to physiology The main premise of coronary physiology is to permit determination of the functional significance of individual stenoses on a per-vessel basis measurable at the time of clinical decision-making process thus providing an objective marker to identify ischemic lesions and therefore patients most likely to benefit from coronary revascularization
Fractional flow reserve FFR is the most widely used pressure-derived invasive physiological index for coronary lesion assessment in contemporary clinical practice FFR is calculated as the ratio of the mean distal coronary pressure Pd to the mean proximal coronary pressure Pa across a stenosis during maximal hyperaemia a condition that is commonly achieved by the intracoronary or intravenous administration of a potent vasodilator agent such as adenosine Based on the results of landmark clinical trials most recent guidelines recommend the use of FFR to identify hemodynamically significant coronary lesions in patients with stable CAD Despite this the worldwide adoption of FFR into current clinical practice remains limited accounting for only 98 of coronary procedures in Switzerland Potential reasons for the low adoption rate of coronary physiology include technical challenges and time consumption related to FFR measurements inadequate or lack of reimbursement physician preferences patient-related discomfort contraindications and costs associated with adenosine or in certain countries no availability of adenosine
The low use of FFR in clinical practice provided a rationale for the development of new invasive physiology indices By negating the need for administration of pharmacologic agents such as adenosine saving time and reducing costs and side effects hyperaemia-free pressure-derived physiological indices were developed to increase adoption of physiology-guided coronary revascularization into routine clinical practice
Fractional flow reserve FFR is the most widely used pressure-derived invasive physiological index for coronary lesion assessment in contemporary clinical practice FFR is calculated as the ratio of the mean distal coronary pressure Pd to the mean proximal coronary pressure Pa across a stenosis during maximal hyperaemia a condition that is commonly achieved by the intracoronary or intravenous administration of a potent vasodilator agent such as adenosine Based on the results of landmark clinical trials most recent guidelines recommend the use of FFR to identify hemodynamically significant coronary lesions in patients with stable CAD Despite this the worldwide adoption of FFR into current clinical practice remains limited accounting for only 98 of coronary procedures in Switzerland Potential reasons for the low adoption rate of coronary physiology include technical challenges and time consumption related to FFR measurements inadequate or lack of reimbursement physician preferences patient-related discomfort contraindications and costs associated with adenosine or in certain countries no availability of adenosine
The low use of FFR in clinical practice provided a rationale for the development of new invasive physiology indices By negating the need for administration of pharmacologic agents such as adenosine saving time and reducing costs and side effects hyperaemia-free pressure-derived physiological indices were developed to increase adoption of physiology-guided coronary revascularization into routine clinical practice
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?:
None