Status:
COMPLETED
Saline-induced Distal to Aortic Coronary Pressure Ratio vs. Resting and Hyperemic Indices of Coronary Artery Stenosis Severity
Lead Sponsor:
University Hospital, Geneva
Conditions:
Coronary Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ph...
Eligibility Criteria
Inclusion
- Subject is ≥18 years of age.
- Subject must be willing to sign a Patient Informed Consent (PIC).
- Coronary artery disease with over 50% angiographic diameter stenosis on visual assessment, undergoing clinically indicated invasive physiological assessment by means of FFR.
- Assessment of non culprit arteries with over 50% angiographic diameter stenosis on visual assessment, in patients presenting with NSTEMI.
Exclusion
- Pregnant and/or breastfeeding females.
- Known allergies to: heparin, contrast medium, adenosine.
- Contra-indication to adenosine.
- Severe renal failure (eGFR ≤ 30 ml/min/m2).
- Ostial stenosis in both the left and right coronary arteries.
- Presence of a chronic total occlusion.
- History of coronary artery bypass graft.
- Acute coronary syndrome.
- Acute myocardial infarction within the preceding two weeks.
- Severe valvular heart disease.
- Left main disease.
- Documented left ventricular ejection fraction (LVEF) ≤30% as documented within maximum 6 months prior to the procedure.
- Decompensated congestive heart failure.
- Extreme hypotension (systolic blood pressure \<100 mmHg)
- Extreme bradycardia (\<40 bpm).
Key Trial Info
Start Date :
January 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04284345
Start Date
January 31 2020
End Date
January 1 2024
Last Update
May 8 2024
Active Locations (1)
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1
Geneva University Hospitals
Geneva, Switzerland