Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000025437
Ethics application status
Approved
Date submitted
8/01/2016
Date registered
15/01/2016
Date last updated
15/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Restoring coronary arteries with drug eluting resorbable stents compared to metal stents in patients with diffuse narrowing. The RESTORE feasibility study
Scientific title
A randomised controlled trial of Rebuilding the lEft anterior deScending artery for LIMA grafTing with biO-ReabsorbablE scaffolds versus conventional management.
Secondary ID [1] 287045 0
Nil known
Universal Trial Number (UTN)
U1111-1172-7821
Trial acronym
RESTORE-LAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjects with diffuse left anterior descending artery disease that is not attractive for surgical revascularization 295519 0
Condition category
Condition code
Cardiovascular 297496 297496 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomised 1:1 ratio to reconstruction of the Left Anterior Descending (LAD) with everolimus eluting bioreabsorbable scaffolds or everolimus eluting metal stents.

The ABSORB bioreabsorbable scaffold will be used. Stents are implanted during a percutaneous coronary intervention (PCI) via catheters placed up a major artery from the wrist or groin under local anaesthetic. The implantation procedure is very similar to that of other stents such as the Xience everolimus eluting metallic stents used in the control arm. Procedure duration may vary depending on the complexity of the lesion.
Intervention code [1] 292264 0
Treatment: Devices
Comparator / control treatment
Everolimus eluting metal stents (Xience) will be used. Stents are implanted during a percutaneous coronary intervention (PCI) via catheters placed up a major artery from the wrist or groin under local anaesthetic. The implantation procedure is very similar to that of other stents such as the ABSORB stents used in the active treatment arm. Procedure duration may vary depending on the complexity of the lesion.
Control group
Active

Outcomes
Primary outcome [1] 295490 0
Efficacy: Anatomical suitability of the LAD for a LIMA anastomosis as assessed on CT coronary angiography after 2 years.
Timepoint [1] 295490 0
Two years post procedure
Primary outcome [2] 297054 0
Safety: MACE (all cause death,MI,or Target vessel revascularisation) after 2 years.
Timepoint [2] 297054 0
Two years post procedure
Secondary outcome [1] 319921 0
First occurence of angina pectoris assessed by Seattle questionaire
Timepoint [1] 319921 0
One and two years post procedure
Secondary outcome [2] 319922 0
Target vessel MACE by review of hospital records
Timepoint [2] 319922 0
Two years post procedure
Secondary outcome [3] 319923 0
Left Ventricular function on echocardiography
Timepoint [3] 319923 0
Two years post procedure
Secondary outcome [4] 319924 0
All MACE as per hospital records and mortality register
Timepoint [4] 319924 0
Two years post procedure
Secondary outcome [5] 319925 0
All cause death as per hospital records and mortality register
Timepoint [5] 319925 0
Two years post procedure
Secondary outcome [6] 319926 0
Stent thrombosis as per review of hospital records
Timepoint [6] 319926 0
Two years post procedure

Eligibility
Key inclusion criteria
1. Diffuse LAD disease greater than or equal 50mm in length that is not attractive for surgical revascularisation due to LAD anatomy as judged by a cardiothoracic surgeon.
2. Reconstruction of the LAD with BRS is technically feasible as judged by an experienced BRS implanter.
3. Preserved antero-apical wall motion
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Reconstruction of the LAD with BVS is not technically feasible due to deliverability.
2. Significally impaired LV systolic function of the anterior wall without demonstrable ischaemia (FFR <0.80 or moderate to large reversible perfusion defect on ischameia testing in the LAD territory)
3. Unable or unlikely to take or tolerate long term DAPT
4. Intolerance to Everolimus
5. Unlikely to survive the duration of the study due to othe comorbidity
6. Advanced renal disease not on haemodialysis (eGFR <30ml/min)
7. Within 48 hour of STEMI
8. Prior revascularisation of the mid to distal LAD with stents or CABG.

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)
Subjects, referring physicians and study personnel assessing outcomes will be blinded to treatment allocation.
Assessors of the CT-outcomes after 2 years will be blinded to the study name and purpose
Allocation will be via an online randomisation module of REDCAP
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random allocation to one of 2 groups in a 1:1 ratio
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used. Proportions will be compared using a Chi-square test. As this is a pilot study no power calculations are relevant

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2016
Actual
Date of last participant enrolment
Anticipated
1/07/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment hospital [1] 4120 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 4121 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 4122 0
Eastern Heart Clinic - Randwick
Recruitment postcode(s) [1] 10048 0
6000 - Perth
Recruitment postcode(s) [2] 10049 0
6150 - Murdoch
Recruitment postcode(s) [3] 10050 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 7022 0
New Zealand
State/province [1] 7022 0
Christchurch

Funding & Sponsors
Funding source category [1] 291602 0
Commercial sector/Industry
Name [1] 291602 0
Abbott Vascular
Country [1] 291602 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway
Crawley,
WA
6009
Country
Australia
Secondary sponsor category [1] 290272 0
Hospital
Name [1] 290272 0
Royal Perth Hospital
Address [1] 290272 0
197 Wellington street
Perth
6000
Western Australia
Country [1] 290272 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293132 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 293132 0
Kirkman House
197 Wellington Street
Perth
Western Australia
Ethics committee country [1] 293132 0
Australia
Date submitted for ethics approval [1] 293132 0
Approval date [1] 293132 0
11/09/2015
Ethics approval number [1] 293132 0

Summary
Brief summary
The coronary arteries supply the heart muscle with oxygen rich blood. The Left Anterior
Descending artery (LAD) supplies the front part of the heart muscle. Narrowing of the coronary arteries can cause angina and if one of the narrowings block off it can cause a heart attack..
Preventative medication can help to relieve or prevent these problems. When the LAD is
narrowed in many places (diffusely diseased) it can often cause angina or breathlessness
and medications alone may not be sufficient to treat the diseased artery. In addition to tablets coronary bypass surgery is often the best treatment when there are many narrowings, but for technical reasons it is not a suitable treatment when the LAD is diffusely diseased. It is still possible to reconstruct the artery using long stents during a coronary catheterisation procedure. Reconstruction of the artery with conventional drug eluting metal stents such as Xience can be a very effective treatment, but leaves the vessel in a permanent metal cage with risk of restenosis and stent thrombosis. The standard Xience stent is a metal stent and contains the drug everolimus to prevent the heart artery from re-narrowing.
Individual case reports show that diffuse disease in the LAD may be reconstructed using
bioreabsorbable scaffolds. The Absorb bioreabsorbable scaffold is made of a special type of plastic consisting of materials called polylactide polymers and copolymers. Over time these materials will gradually break down and be completely resorbed into the artery wall, leaving nothing behind and in principle restoring the natural ability of the artery to change in size in response to the needs of the heart (vasomotion). The Absorb scaffold is also coated with the drug everolimus which helps to prevent the heart artery from re-narrowing. When a narrowing in the arteries is stretched open the scaffolding effect, which prevents the artery from collapsing down again, is needed for only 3-6 months after which the artery grows larger by itself through a process called remodelling. As such the scaffolding effect from metal stent lasts much longer than needed and this can sometimes lead to problems.
In theory the reabsorption of the scaffold over time may allow for future bypass grafting of the vessel if needed . While the bioreabsorbable stent seems like a good idea on many levels and initial study results are encouraging, there is much less experience with this new technology Commercial-in-Confidence and in particular whether the long term effects compared to a modern metal stent are better, worse or the same are not known.
The aim of the trial is to evaluate whether, in addition to medical therapy, reconstructing the LAD with bioreabsorbable vascular scaffolds may improve outcomes versus treatment with standard Xience stents and specifically whether the artery may become suitable for coronary bypass surgery.

The trial is a prospective randomised single blind, blinded end-point assessment; controlled trial






Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58618 0
Prof Carl Schultz
Address 58618 0
Cardiology Department
Royal Perth Hospital Campus, University of Western Australia
197 Wellington Street
Perth
6000
Western Australia
Country 58618 0
Australia
Phone 58618 0
+618 9224-2244
Fax 58618 0
+61 8 9224-2448
Email 58618 0
[email protected]
Contact person for public queries
Name 58619 0
Prof Carl Schultz
Address 58619 0
Royal Perth Hospital
Wellington Street
Perth
6000
Western Australia
Country 58619 0
Australia
Phone 58619 0
+61 8 9224-2244
Fax 58619 0
+61 8 9224-2448
Email 58619 0
[email protected]
Contact person for scientific queries
Name 58620 0
Prof Carl Schultz
Address 58620 0
Royal Perth Hospital
Wellington Street
Perth
6000
Western Australia
Country 58620 0
Australia
Phone 58620 0
+61 8 9224-2244
Fax 58620 0
+61 89224-2448
Email 58620 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
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