ANZCTR - Registration

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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]

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

Condition category

Condition code

Cardiovascular

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]

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]

Efficacy: Anatomical suitability of the LAD for a LIMA anastomosis as assessed on CT coronary angiography after 2 years.

Timepoint [1]

Two years post procedure

Primary outcome [2]

Safety: MACE (all cause death,MI,or Target vessel revascularisation) after 2 years.

Timepoint [2]

Two years post procedure

Secondary outcome [1]

First occurence of angina pectoris assessed by Seattle questionaire

Timepoint [1]

One and two years post procedure

Secondary outcome [2]

Target vessel MACE by review of hospital records

Timepoint [2]

Two years post procedure

Secondary outcome [3]

Left Ventricular function on echocardiography

Timepoint [3]

Two years post procedure

Secondary outcome [4]

All MACE as per hospital records and mortality register

Timepoint [4]

Two years post procedure

Secondary outcome [5]

All cause death as per hospital records and mortality register

Timepoint [5]

Two years post procedure

Secondary outcome [6]

Stent thrombosis as per review of hospital records

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

WA,VIC

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment hospital [2]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [3]

Eastern Heart Clinic - Randwick

Recruitment postcode(s) [1]

6000 - Perth

Recruitment postcode(s) [2]

6150 - Murdoch

Recruitment postcode(s) [3]

3128 - Box Hill

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Christchurch

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Abbott Vascular

Address [1]

299 Lane Cove Road
Macquarie Park, NSW 2113

Country [1]

Australia

Primary sponsor type

University

Name

The University of Western Australia

Address

35 Stirling Highway
Crawley,
WA
6009

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Royal Perth Hospital

Address [1]

197 Wellington street
Perth
6000
Western Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Perth Hospital Ethics Committee

Ethics committee address [1]

Kirkman House
197 Wellington Street
Perth
Western Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/09/2015

Ethics approval number [1]

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

Prof Carl Schultz

Address

Cardiology Department
Royal Perth Hospital Campus, University of Western Australia
197 Wellington Street
Perth
6000
Western Australia

Country

Australia

Phone

+618 9224-2244

Fax

+61 8 9224-2448

carl.schultz@health.wa.gov.au

Contact person for public queries

Name

Carl Schultz

Address

Royal Perth Hospital
Wellington Street
Perth
6000
Western Australia

Country

Australia

Phone

+61 8 9224-2244

Fax

+61 8 9224-2448

carl.schultz@health.wa.gov.au

Contact person for scientific queries

Name

Carl Schultz

Address

Royal Perth Hospital
Wellington Street
Perth
6000
Western Australia

Country

Australia

Phone

+61 8 9224-2244

Fax

+61 89224-2448

carl.schultz@health.wa.gov.au

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

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No additional documents have been identified.

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