Optimization of intracoronary functional coronary lesion severity evaluation by simultaneous intracoronary pressure and flow velocity measurements during baseline conditions, and contrast medium- or regadenoson- induced hyperemia.

Withdrawn

Conditions: cardiac disease
Coronary artery disease
10011082

Registration Number: NL-OMON36985

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

1. Stable angina (CCS class I to 3, or Braunwald class I)
2. Scheduled for PCI or intracoronary evaluation of functional lesion severity (diagnostic catheterization) of at least one coronary lesion in a native coronary vessel of 40 * 80% diameter stenosis on visual estim

Exclusion Criteria

1. Younger than 18 or older than 80 years of age
2. Multiple coronary lesions in the same coronary artery
3. Recent myocardial infarction or revascularization (less than 6 weeks prior to procedure)
4. Previous revascularization of the vessel of interest
5. Severe left ventricular dysfunction (LV ejection fraction less than 30%)
6. Severe renal insufficiency (eGRF according to sMDRD less than 30 mL/min/m2)
7. 50% or more diameter stenosis in left main coronary artery
8. Severe valvular abnormalities
9. Women of childbearing age without a negative pregnancy test or active birthcontrol

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the sensitivity, specificity, and diagnostic accuracy of stenosis<br /><br>resistance index (SR) and instantaneous wave free ratio (iFR) during baseline<br /><br>conditions, as well as SR, and the pressure-drop at a fixed velocity (dPv)<br /><br>during contrast-medium induced sub-maximal hyperemia for myocardial ischemia as<br /><br>assessed by intracoronary adenosine-derived (40µg) HSR. </p><br>

Secondary Outcome Measures