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.

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. - IMPACT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42425

Enrollment

Registered

2015-10-30

Start date

2015-01-28

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis coronary artery disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Left main involvement requiring revascularization.;Cardiac arrhytmia.;Extremely tortuous or calcified coronary arteries that impede adequate physiologic measurements.;Recent (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

Design outcomes

Primary

Measure	Time frame
The resistance induced by the epicardial coronary segment with and without the presence of an over-the-wire micro-catheter during coronary vasodilation.	—

Secondary

Measure	Time frame
The resistance induced by the epicardial coronary segment with and without the presence of an over-the-wire micro-catheter during resting conditions. The available coronary vasodilatory reserve with and without the presence of an over-the-wire micro-catheter using the coronary flow reserve, and the resistive reserve ratio. Stenosis severity with and without the presence of an over-the-wire micro-catheter by means of the distal coronary to aortic pressure ratio during resting conditions. Stenosis severity with and without the presence of an over-the-wire micro-catheter by means of the distal coronary to aortic pressure ratio during coronary vasodilation. The delta stenosis resistance between wire-only and micro-catheter based assessment during vasodilation as a function of stenosis severity identified by angiographic diameter stenosis, resting Pd/Pa and basal stenosis resistance index.	—

Measure

Time frame

The resistance induced by the epicardial coronary segment with and without the presence of an over-the-wire micro-catheter during resting conditions. The available coronary vasodilatory reserve with and without the presence of an over-the-wire micro-catheter using the coronary flow reserve, and the resistive reserve ratio. Stenosis severity with and without the presence of an over-the-wire micro-catheter by means of the distal coronary to aortic pressure ratio during resting conditions. Stenosis severity with and without the presence of an over-the-wire micro-catheter by means of the distal coronary to aortic pressure ratio during coronary vasodilation. The delta stenosis resistance between wire-only and micro-catheter based assessment during vasodilation as a function of stenosis severity identified by angiographic diameter stenosis, resting Pd/Pa and basal stenosis resistance index.

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Countries

Netherlands

Outcome results