This study is designed to objectively document the physiological impact of a micro-catheter on coronary physiology parameters compared with a contemporary 0.014* sensor-equipped guide wire during both basal and hyperaemic conditions, and to identify…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The resistance induced by the epicardial coronary segment with and without the
presence of an over-the-wire micro-catheter during coronary vasodilation.
Secondary outcome
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.
Background summary
The adoption of physiologic indices as fractional flow reserve (FFR) remains
limited, part of which can be attributed to practical ambiguities related to
the use of contemporary sensor-equipped guide wires. Since the mechanical
properties of sensor-equipped guide wires are less refined than routine guide
wires used for PCI, many operators prefer to use their workhorse guide wire for
stent placement. This could be addressed by an over-the-wire system capable of
measuring coronary pressure, while allowing the use of routine flexible
workhorse guide wires to provide stable positioning of the pressure sensor, and
limiting guide wire manoeuvres necessary for physiological assessment and PCI.
However, micro-catheter systems are larger in diameter than guide wires, and it
is unclear to what extend coronary haemodynamics and physiological properties
of the stenosis might be altered by over-the-wire micro-catheters systems
compared to contemporary sensor-equipped guide wires.
Study objective
This study is designed to objectively document the physiological impact of a
micro-catheter on coronary physiology parameters compared with a contemporary
0.014* sensor-equipped guide wire during both basal and hyperaemic conditions,
and to identify boundary conditions for micro-catheter based physiology-guided
coronary intervention.
Study design
A multi-center, single-blinded, randomized , cross-over study.
Study burden and risks
Compared to local practice standards that recommend FFR-guided
revascularization, no additional risks are related to present study. It is in
general considerate that the use of sensor-equipped guide wires is safe. The
appearance of vessel wall damaging occurs in approximately 1 of 1000
procedures, hence the adoption of sensor-equipped guide wires is considered as
local standard care.
3721 Valley Centre Dr #500
San Diego, CA 92130
NL
3721 Valley Centre Dr #500
San Diego, CA 92130
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54889.018.15 |