ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000006640

Ethics application status

Approved

Date submitted

10/12/2013

Date registered

3/01/2014

Date last updated

26/07/2022

Date data sharing statement initially provided

27/03/2019

Date results provided

26/07/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Does the use of intravascular ultrasound improve outcomes of endovascular interventional procedures for peripheral vascular disease of the superficial femoral artery or popliteal artery?

Scientific title

In patients with peripheral vascular disease of the superficial femoral artery or popliteal artery, does the use of intravascular ultrasound and angiography in combination improve the outcome of endovascular interventional procedures, as measured by 1 year primary patency rates, in comparison to the use of angiography alone?

Secondary ID [1]

NIL

Universal Trial Number (UTN)

Nil

Trial acronym

Nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Peripheral Arterial Disease

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study will involve patients undergoing endovascular intervention (angioplasty +/- stenting) for stenosis/occlusion of the superficial femoral artery (SFA) and/or popliteal artery. Imaging guidance is essential for the success of these procedures. Traditionally this guidance has been performed by the use of angiographic imaging. In this intervention intravascular ultrasound will be added as an adjunctive imaging method in additional to angiography. Previous observational studies in the peripheral arteries and studies from the coronary circulation suggest that the use of intravascular ultrasound allows for more accurate sizing of lesion and vessels and more precise balloon and stent sizing and placement. The addition of intravascular ultrasound adds an extra 15 minutes to the length of the procedure. It is hypothesized that the additional of intravascular ultrasound will result in better technical results for the interventional procedure and so reduce complication rates.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The intervention group group will have the procedure guided by a combination of intravascular ultrasound and angiography. The comparator group will have the procedure guided by angiography alone (standard care).

Control group

Active

Outcomes

Primary outcome [1]

Binary restenosis at 12 months- defined as <50% restenosis in the treated segment of the artery. The duplex criteria is a peak velocity ratio >/= 2.4. Duplex ultrasound will be used as the standard non-invasive surveillance modality. Regular surveillance scans will be performed at 3,6 and 12 months, CT, MRI or angiography may also be used if performed for clinical requirements and a 50% reduction in lumen will indicate restenosis in these cases

Timepoint [1]

1, 3, 6 and 12 months post procedure

Secondary outcome [1]

Target lesion revascularisation (TLR) rate - defined as the number of re-interventions performed on treated lesions divided by the total number of primary treatments

Timepoint [1]

One year post procedure

Secondary outcome [2]

Major adverse events (MAEs) - defined as death, cardiovascular event (MI and stroke), target lesion revascularisation (TLR) and major amputation

Timepoint [2]

One year post procedure

Eligibility

Key inclusion criteria

Patients with a stenotic or occlusive lesion(s) in the SFA or popliteal artery in whom endovascular intervention with angioplasty +/- stenting is the most appropriate treatment option based on presenting symptoms, lesion characteristics and medically suitability.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients who are unable to give informed consent due to language difficulties, or physical and/or mental incapacity.
Allergy to iodine based contrast media.
Very short life expectancy (>6 months)

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)

Patient will be enrolled in the study at the time of booking for the procedure (usually in the out-patient clinic or the hospital ward), at least one day before the procedure. The patient will be randomised at the time of the procedure with the interventionist unaware of the randomisation until after the pre-intervention angiography has been performed (to reduce the chance of bias from changes in angiographic methods due to knowledge of whether intravascular ultrasound data will be available during the procedure). Randomisation will be concealed through the use of an online random number generator that will accessed for allocation the subject at the time of the procedure (this is after the time of enrollment in the study).

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table generated by computer software.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The main research question regarding differences in percentage of cases that do not have a >/=50% restenosis and have not required re-intervention between treatment and control group will be addressed utilizing survival analysis. Required sample size was estimated using Log-rank tests subroutine 7 available in PASS 8 sample size estimation software. An overall sample size of 117 subjects (58 in the control group and 59 in the treatment group) will achieve 80% power at a 0.05 significance level to detect a hazard ratio of 0.51 when the proportion surviving in the control group is 0.5. The accrual pattern across time periods is uniform (all periods equal). Hypothesised proportion of cases that do not develop restenosis requiring re-intervention in one year in the control (angiography only) group is 0.5 which is in line with the reported combined literature for angioplasty and stenting. The hypothesised proportion of cases that do not require re-intervention (primary patency) in one year in the treatment (IVUS and angiography) group is equal 0.7. Due to the lack of data in peripheral vascular arteries this estimate has been driven by results from the coronary artery literature. Due to concerns about the generalisability of the coronary evidence to peripheral arteries, the estimated effect of the use of IVUS has been set at the lower end of that stated in the literature. The final required sample size will be overestimated by 25% to accommodate anticipated missing data (based on local data for death rate and loss to follow-up) resulting in 74 subjects to be enrolled in each arm of the trial.
Finally, agreement analyses will be undertaken to assess the degree of equivalence of various quantifiable blood vessels characteristics obtained from angiography and IVUS. The analyses will include reporting Bland-Altman limits of agreement. Fixed and proportional biases will be assessed with attention given to using an approach which will appropriate address that neither angiography or IVUS can be perceived as “golden standard”. Sample size determined by the primary outcome considerations should be more than sufficient for assessing agreement as per various rules of thumb reported in the agreement literature.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2014

Actual

9/08/2014

Date of last participant enrolment

Anticipated

16/03/2020

Actual

11/03/2020

Date of last data collection

Anticipated

15/03/2021

Actual

16/04/2021

Sample size

Target

150

Accrual to date

Final

150

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Flinders Medical Centre

Address [1]

Flinders Drive
Bedford Park
South Australia 5042

Country [1]

Australia

Primary sponsor type

Hospital

Name

Department of Vascular Surgery, Flinders Medical Centre

Address

Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

The Flats G5 – Rooms 3 and 4
Flinders Drive
Bedford Park
South Australia 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/09/2013

Approval date [1]

27/09/2013

Ethics approval number [1]

453.13

Summary

Brief summary

Narrowing or occlusion of the arteries of the lower limb, caused by atherosclerotic lesions, can lead to leg pain, ulceration and ultimately amputation. Endovascular revascularisation is a procedure in which the artery opened through the use of balloons or stents inserted under the guidance of a special x-ray technique called angiography. These procedures have a high rate of failure with about half developing a >/=50% narrowing (or restenosis) within a year. Much of this failure rate is attributed to technical factors such as incorrect size of catheter or incorrect positioning and in part may relate to the limited view provided by angiography. Intravascular ultrasound (IVUS) is an alternative imaging method that provides a more complete view of the artery. It has been shown that IVUS adds more information when combined with angiography but it is unclear whether this results in changes to treatment and whether this then results in better outcomes for patients.
This aim of this study is to investigate whether the addition of IVUS improves the outcomes for endovascular revascularisation.
This is a randomised control trial comparing endovascular revascularisation procedures guided by angiography with procedures guided by both angiography and IVUS. The study sample of 150 patients will be recruited from patients requiring treatment of lesions in the superficial femoral or popliteal arteries. Patients will be randomised into two groups of equal size; a control group having angiography guidance only and a second group having both angiography and IVUS guidance. All patients will have non-invasive tests of endothelial function (tests of the functioning the inner surface of the artery – an essential component in maintaining vascular wellbeing) before their and after the procedure as well as the standard blood tests and regular surveillance imaging that is normally scheduled for patients after these procedures.
The primary outcome measure will be >/=50% restenosis of the treated artery. This degree of restenosis requires re-intervention to reopen the artery. At this point the original procedure will be deemed to have failed for the purposes of analysis. The restenosis rate will be compared for each group.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Richard Allan

Address

Dept of Vascular Surgery
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042

Country

Australia

Phone

+61 402395505

Fax

richard.allan@sa.gov.au

Contact person for public queries

Name

Richard Allan

Address

Dept of Vascular Surgery
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042

Country

Australia

Phone

61 8 82046796

Fax

richard.allan@health.sa.gov.au

Contact person for scientific queries

Name

Richard Allan

Address

Dept of Vascular Surgery
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042

Country

Australia

Phone

61 8 82046796

Fax

richard.allan@health.sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Ethics committee approval for IPD sharing has not requested

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

Source	Title	Year of Publication	DOI
Embase	Comparison of Angiographic Dissection Classification Systems in the Femoropopliteal Arteries Using IVUS Validation and Reliability Testing.	2022	https://dx.doi.org/10.1177/15266028211047952
Embase	The Impact of Intravascular Ultrasound on Femoropopliteal Artery Endovascular Interventions: A Randomized Controlled Trial.	2022	https://dx.doi.org/10.1016/j.jcin.2022.01.001
Embase	Accuracy and Reliability of Peripheral Artery Calcium Scoring Systems Using an Intravascular Ultrasound Reference Standard.	2023	https://dx.doi.org/10.1016/j.avsg.2022.11.014

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

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