Trial Review

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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 information initially 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] 303935 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Calcified coronary artery 321519 0
Condition category
Condition code
Cardiovascular 319275 319275 0 0
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] 320243 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327157 0
Incidence of major adverse cardiac events (MACE) as assessed by patient medical records.
Timepoint [1] 327157 0
Within 30 days of procedure
Primary outcome [2] 327158 0
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] 327158 0
Upon discharge from hospital.
Secondary outcome [1] 393991 0
Ability to deliver the IVL catheter across the target lesion determined via intravascular ultrasound (IVUS) and optical coherence tomography (OCT).
Timepoint [1] 393991 0
Within the episode
Secondary outcome [2] 396025 0
Delivery of lithotripsy without angiographic complications immediately after IVL
Timepoint [2] 396025 0
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?
No
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
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19089 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 33646 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 308320 0
Commercial sector/Industry
Name [1] 308320 0
Shockwave Medical, Inc.
Country [1] 308320 0
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] 309129 0
None
Name [1] 309129 0
Address [1] 309129 0
Country [1] 309129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308295 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 308295 0
The Townsville Hospital, IMB 52, PO Box 670, Townsville QLD 4810
Ethics committee country [1] 308295 0
Australia
Date submitted for ethics approval [1] 308295 0
Approval date [1] 308295 0
03/02/2021
Ethics approval number [1] 308295 0

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 110214 0
Dr Michael Zhang
Address 110214 0
Mackay Base Hospital 475 Bridge Rd, Mackay, QLD, 4740
Country 110214 0
Australia
Phone 110214 0
+61 7 4885 7953
Fax 110214 0
Email 110214 0
[email protected]
Contact person for public queries
Name 110215 0
Dr Michael Zhang
Address 110215 0
Mackay Base Hospital 475 Bridge Rd, Mackay, QLD, 4740
Country 110215 0
Australia
Phone 110215 0
+61 7 4885 7953
Fax 110215 0
Email 110215 0
[email protected]
Contact person for scientific queries
Name 110216 0
Dr Matthew Hiskens
Address 110216 0
Mackay Base Hospital 475 Bridge Rd, Mackay, QLD, 4740
Country 110216 0
Australia
Phone 110216 0
+61 7 4885 6793
Fax 110216 0
Email 110216 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All IPD that underlie results in a publication.
When will data be available (start and end dates)?
From January 1, 2022 with no end date.
Available to whom?
Public accessibility.
Available for what types of analyses?
Analysis will be undertaken by research team.
How or where can data be obtained?
By emailing the principal investigator [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11351Study protocol    381789-(Uploaded-12-04-2021-15-22-57)-Study-related document.docx
11352Informed consent form    381789-(Uploaded-12-04-2021-15-22-28)-Study-related document.docx
11353Ethical approval    381789-(Uploaded-12-04-2021-15-22-00)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo DOI:https://doi.org/10.1016/j.hlc.2022.06.598 381789-(Uploaded-09-11-2022-12-06-04)-Other results publication.pdf

Documents added automatically
No additional documents have been identified.