Status:
RECRUITING
Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Coronary Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate judgement of the prognostic significance of LM stenosis is essential to improve patients' prognosis. Recent...
Eligibility Criteria
Inclusion
- Unprotected LM lesion \[midshaft, and distal bifurcation (Medina 1,1,1 or 1,1,0 or 1,0,1 or 1,0,0)\] of 30% to 80% angiographic diameter stenosis (DS) on visual estimation or equivocal disease by angiography.
- Age ≥18 years.
- Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent prior to any study-specific procedures.
Exclusion
- Significant distal lesions (\>50% angiographic DS on visual estimation within the left anterior descending artery \[LAD\] or left circumflex artery \[LCX\], except for ostium of LAD or LCX or diseased side branch \[e.g. diagonal branch, obtuse marginal branch\])
- Ostial LM disease.
- Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI).
- LM In-stent restenosis.
- Previous coronary stenting of the left coronary system.
- Chronic total occlusion.
- Previous coronary artery bypass graft.
- Previous MI related to the left coronary artery.
- Occurrence of ventricularization or hypotension during engagement of the LM ostial lesion.
- The presence of hemodynamic instability.
- Known renal insufficiency (serum creatinine \>1.5mg/dL or receiving dialysis).
- Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
- Life expectancy less than 1 year.
- Contraindication or known allergy against protocol-required medications including heparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine.
- Body mass index \>35kg/m2.
- Complex congenital heart disease other than anomalous coronary origins alone.
- Ventricular septal defect.
Key Trial Info
Start Date :
May 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03820492
Start Date
May 28 2019
End Date
December 31 2026
Last Update
February 9 2023
Active Locations (13)
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1
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France, 63000
2
Institute Mutualiste Montsouris
Paris, France, 75014
3
Centre Cardiologique du Nord
Saint-Denis, France, 75014
4
Universitätsklinikum Giessen Justus-Liebig Universität
Giessen, Hesse, Germany, 35392