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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
Scientific title
Expansion of Intracoronary Stents by Low Pressure Oversizing Versus High Pressure Inflation: A Randomised Intracoronary Ultrasound Controlled Study
Secondary ID [1] 0 0
2013/167
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Angioplasty and Stenting 0 0
Single de Novo Coronary Artery Stenoses 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of stents which are optimally deployed as assessed against the MUSIC criteria
Timepoint [1] 0 0
Immediately after stent is deployed until optimal deployment is achieved
Secondary outcome [1] 0 0
Clinical endpoints including death, myocardial infarction, coronary artery bypass surgery, repeat percutaneous intervention, stent thrombosis, myonecrosis
Timepoint [1] 0 0
1-3 days following procedure and at 6 months

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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindication to antiplatelet therapy;
* Ostial lesion;
* Excessive vessel tortuosity;
* Lesion at a significant bifurcation (subbranch = 2mm in diameter);
* Suspected intracoronary thrombus.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2016
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Department of Cardiology - Liverpool
Recruitment postcode(s) [1] 0 0
2170 - Liverpool

Funding & Sponsors
Primary sponsor type
Government body
Name
Sydney South West Area Health Service
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT02128412
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Craig Juergens, Cardiologist
Address 0 0
South West Sydney, Liverpool
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02128412