Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000789864
Ethics application status
Approved
Date submitted
19/07/2012
Date registered
25/07/2012
Date last updated
27/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Pressure Difference Measurements Across Narrowed Diseased Arteries Using a New Pressure Sensor Compared to a Commercially Available Pressure Sensor
Scientific title
ACIST Rapid Exchange Monorail Pressure Sensor (MPS) for the Measurement of Fractional Flow Reserve (FFR) Compared with Measurements from the Radi PressureWire in Patients with Coronary Arterial Disease
Secondary ID [1] 280847 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
ACCESS-NZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Arterial Disease (CAD) 286914 0
Condition category
Condition code
Cardiovascular 287242 287242 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 285272 0
Diagnosis / Prognosis
Intervention code [2] 285273 0
Treatment: Devices
Comparator / control treatment
Radi PressureWire. Using standard inverventional catheter placement techniques, Radi pressure wire 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 as close together in time as possible.
Control group
Active

Outcomes
Primary outcome [1] 287524 0
Primary Outcome 1: fractional flow reserve (FFR) measurement, as taken directly from the MPS and Radi PressureWire systems.
Timepoint [1] 287524 0
Timepoint 1: peri-procedure
Secondary outcome [1] 298317 0
Secondary Outcome 1: device success rate, as defined by a valid FFR reading by the MPS System where a valid FFR measurment was taken using the Radi PressureWire
Timepoint [1] 298317 0
Timepoint 1: peri-procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4406 0
New Zealand
State/province [1] 4406 0
Waikato
Country [2] 4407 0
New Zealand
State/province [2] 4407 0
Auckland

Funding & Sponsors
Funding source category [1] 285631 0
Commercial sector/Industry
Name [1] 285631 0
ACIST Medical Systems
Country [1] 285631 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
ACIST Medical Systems
Address
7905 Fuller Road
Eden Prairie, MN 55344
Country
United States of America
Secondary sponsor category [1] 284465 0
None
Name [1] 284465 0
Address [1] 284465 0
Country [1] 284465 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287628 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 287628 0
c/o Ministry of Health
Level 3, Bridgewater Building
130 Grantham St
Hamilton
Waikato 3204
Ethics committee country [1] 287628 0
New Zealand
Date submitted for ethics approval [1] 287628 0
Approval date [1] 287628 0
29/06/2012
Ethics approval number [1] 287628 0
NTY/12/05/043

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34437 0
Address 34437 0
Country 34437 0
Phone 34437 0
Fax 34437 0
Email 34437 0
Contact person for public queries
Name 17684 0
Dennis Crane
Address 17684 0
ACIST Medical Systems
7905 Fuller Road
Eden Prairie, MN 55344
Country 17684 0
United States of America
Phone 17684 0
+1 952 253 4515
Fax 17684 0
+1 952 941 4648
Email 17684 0
[email protected]
Contact person for scientific queries
Name 8612 0
Dr. Madhav Menon
Address 8612 0
Waikato Hospital
Pembroke Street
Hamilton
Waikato 3240
Country 8612 0
New Zealand
Phone 8612 0
+64 7 8398899
Fax 8612 0
Email 8612 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAssessment of coronary fractional flow reserve using a monorail pressure catheter: The first-in-human ACCESS-NZ trial.2015https://dx.doi.org/10.4244/EIJV11I3A51
N.B. These documents automatically identified may not have been verified by the study sponsor.