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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

Trial registered on ANZCTR

Registration number

ACTRN12621000697886

Ethics application status

Approved

Date submitted

12/04/2021

Date registered

7/06/2021

Date last updated

9/11/2022

Date data sharing statement initially provided

7/06/2021

Date results provided

9/11/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Intravascular Lithotripsy Catheter Balloon for Calcified Coronary Artery Pilot Study

Scientific title

Pilot Study of Incidence of Major Adverse Cardiac Events and Effectiveness of Stent Delivery after Intravascular Lithotripsy Catheter Balloon for Calcified Coronary Artery in Adults

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Calcified coronary artery

Condition category

Condition code

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intravascular Lithotripsy (IVL) is a technique based on lithotripsy, an established treatment strategy for renal calcification, in which multiple lithotripsy emitters mounted on a traditional balloon catheter platform create diffusive pulsatile mechanical energy to disrupt calcium within the vessel wall at low inflation pressures.
For coronary artery calcification, the recent Disrupt CAD III study reported high rates of device success, safety and performance of coronary IVL in vessel preparation of calcified stenotic coronary lesions prior to stent implantation.
The Shockwave Medical (Santa Clara, CA, USA) IVL system and coronary IVL catheter consist of a fluid-filled balloon angioplasty catheter and guidewire. Lithotripsy emitters are housed in the 12mm balloon segment. Each catheter is single use and can deliver a total of 80 IVL pulses.
All participants will have the procedure completed by a cardiologist with minimum 5 years experience in other forms of percutaneous coronary intervention who is trained in using the Shockwave IVL. A single IVL intervention will be undertaken in the Mackay Base Hospital Cardiac Catheterisation laboratory. The IVL catheter will be inserted and delivered over guidewire. Atherectomy devices and cutting/scoring balloons will not be used. The IVL balloon will be inflated to 4 atm and 10 IVL pulses will be delivered followed by inflation of the balloon to 6 atm. This will be continued until the balloon has expanded to full capacity, whereby the stent can be implanted. Procedure duration is anticipated to be a mean (+/- SD) of 70 (+/- 30) mins. Patient medical records will be used to monitor adherence to the intervention and patient outcomes.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Incidence of major adverse cardiac events (MACE) as assessed by patient medical records.

Timepoint [1]

Within 30 days of procedure

Primary outcome [2]

Procedural success defined as stent delivery with a residual stenosis <50% as determined by CT coronary angiography (CTCA) and without in-hospital MACE.

Timepoint [2]

Upon discharge from hospital.

Secondary outcome [1]

Ability to deliver the IVL catheter across the target lesion determined via intravascular ultrasound (IVUS) and optical coherence tomography (OCT).

Timepoint [1]

Within the episode

Secondary outcome [2]

Delivery of lithotripsy without angiographic complications immediately after IVL

Timepoint [2]

Within the episode

Eligibility

Key inclusion criteria

• Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure or if troponin is elevated, concomitant CK must be normal
• The target vessel must have a TIMI flow 3 at baseline
• Patients with significant (> 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
• Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life
• Single lesion stenosis of protected LMCA, or LAD, RCA or LCX artery > 50% in a reference vessel of 2.5mm – 4.0 mm diameter and < 32 mm length
• Presence of calcification within the lesion on both sides of the vessel as assessed by angiography
• Planned treatment of single lesion in one vessel
• Ability to pass a 0.014’’ guide wire across the lesion
• Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
• Patient is able and willing to comply with all assessments in the study

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Concomitant use of other techniques to deal CAC such as atherectomy and special balloons
• Severe renal failure
• Severe anaemia
• Previous PCI within 30 days of planned procedure
• Patients not suitable for consenting such as severe memory impairment
• Acute coronary syndrome within 1 month from planned procedure
• Severe Heart Failure (NYHA III or IV)
• Unable to tolerate dual antiplatelet agents (Aspirin + clopidogrel or ticargrelor or prasugrel) for 1 year for any reason
• Contrast allergy
• Active infection

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised 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

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2021

Actual

2/08/2021

Date of last participant enrolment

Anticipated

Actual

14/12/2021

Date of last data collection

Anticipated

Actual

14/12/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Mackay Base Hospital - Mackay

Recruitment postcode(s) [1]

4740 - Mackay

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Shockwave Medical, Inc.

Address [1]

5403 Betsy Ross Dr., Santa Clara, CA 95054

Country [1]

United States of America

Primary sponsor type

Hospital

Name

Mackay Hospital and Health Service

Address

Mackay Base Hospital 475 Bridge Rd, Mackay, QLD, 4740

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Townsville Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

The Townsville Hospital, IMB 52, PO Box 670, Townsville QLD 4810

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/02/2021

Ethics approval number [1]

Summary

Brief summary

Coronary calcification complicates the delivery and expansion of stents and is a risk factor for major adverse cardiovascular events such as cardiac death or myocardial infarction. Intravascular lithotripsy (IVL) provides a variation to currently available percutaneous coronary interventions by delivering an acoustic pressure wave within the balloon to modify calcium, and in doing so enhancing vessel accessibility and providing a better environment for stent deployment. IVL has shown safety and effectiveness in multicentre studies, and our study will confirm the benefits of IVL in the context of our local facility
for optimising stent implantation in calcified coronary lesions.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Michael Zhang

Address

Mackay Base Hospital 475 Bridge Rd, Mackay, QLD, 4740

Country

Australia

Phone

+61 7 4885 7953

Fax

[email protected]

Contact person for public queries

Name

Michael Zhang

Address

Mackay Base Hospital 475 Bridge Rd, Mackay, QLD, 4740

Country

Australia

Phone

+61 7 4885 7953

Fax

[email protected]

Contact person for scientific queries

Name

Matthew Hiskens

Address

Mackay Base Hospital 475 Bridge Rd, Mackay, QLD, 4740

Country

Australia

Phone

+61 7 4885 6793

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Public accessibility.

Conditions for requesting access:
• -

What individual participant data might be shared?

• All IPD that underlie results in a publication.

What types of analyses could be done with individual participant data?

• Analysis will be undertaken by research team.

When can requests for individual participant data be made (start and end dates)?

From:
From January 1, 2022 with no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• By emailing the principal investigator [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Attachment
11351	Study protocol	Study-related document.docx
11352	Informed consent form	Study-related document.docx
11353	Ethical approval	Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically