Influence of over-the-wire micro-catheters on coronary haemodynamics and the accuracy of physiological indices for assessing the functional significance of intermediate coronary stenoses.

Completed

Conditions: atherosclerosis
coronary artery disease
10011082

Registration Number: NL-OMON42425

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

Inclusion Criteria

Age > 18 years.;Presence of at least one epicardial stenosis in a native coronary artery, requiring physiological assessment according to the European Society of Cardiology Myocardial Revascularization Guidelines.;Vessel size at least 2.5mm in diameter as visually assessed on the diagnostic angiogram.;Presence of stable; Canadian Cardiovascular Society (CCS) score I-III.;Willing to participate and able to understand, read and sign the informed consent document before the scheduled procedure.

Exclusion Criteria

Left main involvement requiring revascularization.;Cardiac arrhytmia.;Extremely tortuous or calcified coronary arteries that impede adequate physiologic measurements.;Recent (<6 weeks) myocardial infarction (STEMI or NSTEMI).;Severe valvular abnormalities that require surgery. ;Severely impaired left ventricular (LV) function (LV ejection fraction < 30%);LV hypertrophy (>13mm septal wall thickness). ;Unable to undergo percutaneous intervention or receive adenosine (severe reactive airway disease, severe hypotension or high-grade Atrio-Ventricular (AV) block in the absence of a pacemaker. ;Collateral formation in target vessel.;CABG to target vessel.;Tandem stenoses.;Ostial lesions.;Renal failure (MDRD calculated eGFR of <30). ;Pregnancy or planned pregnancy within 12 months after the procedure.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The resistance induced by the epicardial coronary segment with and without the<br /><br>presence of an over-the-wire micro-catheter during coronary vasodilation.</p><br>

Secondary Outcome Measures