None listed
Conditions
Brief summary
The primary objective of this study is to assess the relationship in pressure measurements, specifically fractional flow reserve (FFR) measurements, between a new pressure catheter from ACIST Medical Systems and the Radi wire.
Interventions
ACIST Medical Systems Monorail Pressure Sensor (MPS) Catheter. Using standard inverventional catheter placement techniques, MPS catheter's pressure sensor is placed just distal to a vessel stenosis and measures the distal blood pressure. In combination with the aortic pressure measured from the hospital's hemodynamic monitor, the MPS system's console displays the aortic and distal blood pressures and calculates fractional flow reserve (FFR).
In a single procedure expected to last under an hour
ACIST Medical Systems Monorail Pressure Sensor (MPS) Catheter. Using standard inverventional catheter placement techniques, MPS catheter's pressure sensor is placed just distal to a vessel stenosis and measures the distal blood pressure. In combination with the aortic pressure measured from the hospital's hemodynamic monitor, the MPS system's console displays the aortic and distal blood pressures and calculates fractional flow reserve (FFR). In a single procedure expected to last under an hour, both the MPS and the Radi PressureWire are introduced into the vessel and measurements are made from both systems, using a nonrandomized crossover trial design, as close together in time as possible. The MPS system differs from the Radi PressureWire in that it is mounted on a Monorail catheter.
Sponsors
ACIST Medical Systems
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years of age or older Clinical indication for coronary angiography Vessel reference diameter of target lesion is >= 2.5 millimeter, as assessed by the operator Vessel has a TIMI flow = 3
Exclusion criteria
Known hypersensitivity or contraindication to aspirin, heparin, without adequate alternative medications Known sensitivity to adenosine High degree of AV block NYHA Class IV heart failure Evidence of active infection on the day of the index procedure Target vessel has angiographically visible or suspected thrombus Target lesion is within a bypass graft Angiographic evidence of a dissection prior to initiation of Radi wire measurements
Outcome results
None listed