Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02128412
Registration number
NCT02128412
Ethics application status
Date submitted
28/04/2014
Date registered
1/05/2014
Date last updated
17/10/2016
Titles & IDs
Public title
IVUS Controlled Stenting
Query!
Scientific title
Expansion of Intracoronary Stents by Low Pressure Oversizing Versus High Pressure Inflation: A Randomised Intracoronary Ultrasound Controlled Study
Query!
Secondary ID [1]
0
0
2013/167
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Coronary Angioplasty and Stenting
0
0
Query!
Single de Novo Coronary Artery Stenoses
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Devices - Oversized stent deployed at low pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)
Treatment: Devices - Stent deployed at high pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)
Active comparator: Stent oversize group - Oversized stent deployed at low pressure:
A stent premounted on a balloon with a nominal diameter halfway between the lumen diameter and the true vessel diameter (approximated by external elastic lamina) as assessed by IVUS. This will be based on the smallest of the vessel reference diameters proximal and distal to the lesion. In addition the vessel diameter must be greater than this diameter throughout the length of the lesion. This stent will be implanted at an inflation pressure of 10 atmospheres or less for at least 15 seconds and a second IVUS will be performed to assess the end point.
Active comparator: High pressure group - Stent deployed at high pressure:
A stent premounted on a balloon with a nominal diameter approximately equal to the vessel segment lumen reference diameter as previously assessed by IVUS will be used. This stent will be implanted at an inflation pressure of 14 atmospheres or more for at least 15 seconds and a second IVUS will be performed to assess the end point
Treatment: Devices: Oversized stent deployed at low pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)
Stent can include both bare metal stents and drug eluting stents. Depending on availabilities, different stent brands may be used.
Treatment: Devices: Stent deployed at high pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)
Stent can include both bare metal stents and drug eluting stents. Depending on availabilities, different stent brands may be used.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of stents which are optimally deployed as assessed against the MUSIC criteria
Query!
Assessment method [1]
0
0
The criteria for optimal stent expansion are:
1. Complete apposition of the stent over its entire length against the vessel wall.
2a. In stent minimal luminal area (MLA) \>= 90% of the average reference luminal area or \>=100% of lumen area of the reference segment with the lowest lumen area.
In stent lumen area of proximal stent entrance \>= 90% of proximal lumen area. 2b. Where the instent luminal area is in excess of 9.0 mm2 , the following criteria apply: In stent MLA \> 80% of the average reference lumen area or \>=90% of lumen area of the reference segment with the lowest lumen area.
In stent lumen area of proximal stent entrance \>= 90% of proximal lumen area. 3. Symmetric stent expansion defined by lumen diameter (LD)min / LD max \>= 0.7
A less rigorous criteria for stent expansion will also be assessed:
1. In stent MLA \> 80% of the average reference lumen area; \&
2. Complete apposition of the stent over its entire length against the vessel wall
Query!
Timepoint [1]
0
0
Immediately after stent is deployed until optimal deployment is achieved
Query!
Secondary outcome [1]
0
0
Clinical endpoints including death, myocardial infarction, coronary artery bypass surgery, repeat percutaneous intervention, stent thrombosis, myonecrosis
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
1-3 days following procedure and at 6 months
Query!
Eligibility
Key inclusion criteria
* Patients who are scheduled for a coronary angioplasty and stenting
* Single de novo artery stenosis are eligible for this study
* Target lesion needs to be less than 30mm long and located in a vessel more than 2.5 mm in diameter
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Contraindication to antiplatelet therapy;
* Ostial lesion;
* Excessive vessel tortuosity;
* Lesion at a significant bifurcation (subbranch = 2mm in diameter);
* Suspected intracoronary thrombus.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
UNKNOWN
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/11/2016
Query!
Actual
Query!
Sample size
Target
40
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Department of Cardiology - Liverpool
Query!
Recruitment postcode(s) [1]
0
0
2170 - Liverpool
Query!
Funding & Sponsors
Primary sponsor type
Government body
Query!
Name
Sydney South West Area Health Service
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Stent placement is now widely accepted to improve the results of angioplasty (an operation to widen the blood vessel) and decreasing the need for further surgery. Despite their worldwide acceptance, stent usage is still limited by renarrowing which occurs within the stent (restenosis) in some patients within the first six months. In addition there still exists a small risk of heart attacks soon after the stent is placed. The purpose of this study is to test the safety and tolerability of trying to place the stents using a different strategy of using low pressure oversized balloon inflations as opposed to the usual high pressure balloon inflations. This may reduce injury to the artery and reduce the chance of renarrowing of the stent. In order to ensure this is a safe and effective way of performing the procedure the investigators intend to use an Intravascular ultrasound (IVUS) catheter to look from inside the artery at the stents. IVUS has proven to be the best way of ensuring optimal stent placement. Primary hypothesis: Stents will be equally well expanded and apposed using a strategy of oversized stenting at normal inflation pressures ( \< 10 atmospheres ) as compared to high pressure inflation (=14 atmospheres) as guided by intravascular ultrasound imaging. Secondary Hypothesis: There will be no difference in acute clinical endpoints (death, myocardial infarction, urgent revascularisation or stent thrombosis) using a strategy of oversized stenting at normal inflation pressure as compared to high pressure inflation. Tertiary Hypothesis: If the above is shown to be true the investigators would hope to expand the study in order to reveal a decrease in stent restenosis using a strategy of lower pressure balloon inflations. The investigators will assess the deployment characteristics of drug eluting versus bare metal stents
Query!
Trial website
https://clinicaltrials.gov/study/NCT02128412
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Craig Juergens, Cardiologist
Query!
Address
0
0
South West Sydney, Liverpool
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02128412
Download to PDF