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New treatment option for Coronary Stenosis
Official title Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT
ClinicalTrials.gov ID: NCT03820492
What this study is testing
- What it's testing
- 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. Recently, fractional flow reserve (FFR) has become widespread practice and carries a Class Ia recommendation to assess functional significance of intermediate coronary stenosis in patients with stable angina.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- Age ≥18 years.
- Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent prior to any study-specific...
You likely can't join if
- Significant distal lesions (\>50% angiographic DS on visual estimation within the left anterior descending artery [LAD] or left circumflex artery...
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
- Paris, France
- Saint-Denis, France
- Giessen, Hesse, Germany
- Erlangen, Germany
- Ageo, Japan
- Gifu, Japan
- Nagano, Japan
- Osaka, Japan
- Saitama, Japan
- Sapporo, Japan
- Bern, Switzerland
- Lausanne, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France; Paris, France; Saint-Denis, France; Giessen, Hesse, Germany; Erlangen, Germany; Ageo, Japan and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.