Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000436673
Ethics application status
Approved
Date submitted
22/03/2023
Date registered
1/05/2023
Date last updated
24/03/2024
Date data sharing statement initially provided
1/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Shockwave Medical Mini C Flex Feasibility Study
Scientific title
Prospective, Multicenter, Single-Arm, Feasibility Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave Mini C Flex Coronary IVL Catheter in individuals undergoing Non-Emergent PCI.
Secondary ID [1] 309128 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 329222 0
Condition category
Condition code
Cardiovascular 326182 326182 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Mini C Flex Feasibility Study is being conducted to assess the safety and performance of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Mini C Flex IVL Catheter for the treatment of heavily calcified, stenotic de novo coronary arteries prior to stenting.

The Shockwave Mini C Flex IVL Catheter will be used in a cardiac angiography laboratory and delivered by an interventional cardiologist with specific skills in managing subjects with severely calcified and heavily stenosed coronary arteries. Subjects may have one coronary artery treated with the Shockwave Medical Mini C System.

The catheter will be inserted into a peripheral artery over a guidewire. The catheter will then be delivered to the affected coronarry artery and pressurised before pulses are delivered. The procedure will take approximately one hour.

Post operative care is in alignment with what is considered to be standard of care for subjects undergoing such a procedure. The study follow up is also in alignment with standard of care practices for subjects with this degree of coronary artery disease. This post procedure and follow up care involves monitoring for cardiac complications and the administration of medications. Such information would be gained from the subject's medical history and any resulting diagnostic tests.
Intervention code [1] 325577 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334060 0
Incidence of major adverse cardiac events (MACE) within 30 days of the index procedure. MACE (CEC adjudicated) is defined as:
• Cardiac death; or
• Myocardial infarction (MI) using the Fourth Universal Definition; or
• Target vessel revascularization (TVR) defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
This will be analysed by assessing subjects medical history and records as well as any other resulting diagnostic tests.
Timepoint [1] 334060 0
Within 30 days of the index (treatment) procedure
Secondary outcome [1] 419221 0
MACE at 6, and 12 months based upon assessment of the subject's medical records and medical history.
Timepoint [1] 419221 0
At 6 months and 12 months following the index procedure.

Eligibility
Key inclusion criteria
General Inclusion Criteria
1. Subject is greater than or equal to 18 years of age
2. Subject is able and willing to comply with all assessments in the study.
3. Subjects with native coronary artery disease including stable or unstable angina or silent ischemia associated with the target coronary artery that are suitable for non-emergent PCI
4. Biomarkers (troponin) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure.
5. Left ventricular ejection fraction greater than 25%
6. Subject signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
7. Estimated life expectancy greater than 1 year.

Angiographic Inclusion Criteria
8. The target lesion must be a de novo coronary lesion that has not been previously treated successfully with any interventional procedure
9. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with stenosis greater than or equal to 70%
10. The target vessel reference diameter must be greater than or equal to 2.5 mm and less than or equal to 4.0 mm
11. The lesion length must not exceed 40 mm
12. The target lesion must meet one of the following criteria:
a) Evidence of moderate or severe calcification at the lesion site and with TIMI flow 0 or 1 at baseline. Moderate calcification defined as angiography with densities noted only during the cardiac cycle prior to contrast injection; severe calcification defined as: angiography with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall), OR
b) Documented evidence of a prior device un-crossable lesion (>3 days prior to the index procedure)
13. Guidewire must be in true lumen, distal to the lesion, and not subintimal, prior to insertion of Mini C catheter (antegrade wire technique only)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General Exclusion Criteria
1. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
2. Subject is participating in another research study involving an investigational agent including pharmaceutical, biologic, or medical device that has not reached the primary endpoint
3. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
4. Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines
5. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
6. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as clinical symptoms consistent with an acute coronary syndrome with troponin greater than 1 times the local laboratory’s upper limit of normal
7. Subject has acute or chronic renal disease with eGFR less than 30 ml/min/1.73m2 (using CKD-EPI formula)
8. History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit
9. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months
10. Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
11. Coagulopathy, including but not limited to platelet count <100,000 or International Normalized ratio (INR) greater than 1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
12. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count greater than 750,000 or other disorders
13. Uncontrolled diabetes defined as a HbA1c ?greater than or equal to 10%
14. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
15. Subjects with clinical evidence of cardiogenic shock
16. Uncontrolled severe hypertension (systolic BP greater than 180 mm Hg or diastolic BP greater than 110 mm Hg)
17. Subjects with a life expectancy of less than 1 year
18. Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure
19. Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure
20. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
21. Planned use of atherectomy, scoring or cutting balloon, sub-intimal reentry device, or any investigational device other than coronary IVL

Angiographic Exclusion Criteria
22. Evidence of moderate or severe calcification at the lesion site and with TIMI flow 2 to3 at baseline
23. Target vessel is excessively tortuous defined as the presence of two or more bends greater than 90º or three or more bends greater than 75º
24. Evidence of a serious angiographic complication in the target vessel prior to treatment with coronary IVL (severe dissection (Type D to F), perforation, abrupt closure, persistent slow-flow or persistent no reflow)
25. Definite or possible thrombus by angiography in the target vessel
26. Evidence of aneurysm in target vessel within 10 mm of the target lesion
27. Second lesion with greater than 50% stenosis in the same target vessel as the target lesion including its side branches
28. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
29. Previous stent within the target vessel
30. Previous stent within 5 mm of the target lesion regardless of the timing of its implantation
31. Failure to successfully cross the guidewire across the target lesion
32. Use of antegrade dissection and reentry (ADR), retrograde guidewire (RW), or retrograde dissection and reentry (RDR) crossing technique at any time during the procedure.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be reported. The sample size is 20 subjects (being a feasibility study) which would be too small to generate statistical significance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/05/2023
Actual
30/05/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
20
Accrual to date
9
Final
Recruitment outside Australia
Country [1] 25309 0
United Kingdom
State/province [1] 25309 0
London, Cardiff, Bristol

Funding & Sponsors
Funding source category [1] 313331 0
Commercial sector/Industry
Name [1] 313331 0
Shockwave Medical Inc.
Country [1] 313331 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Shockwave Medical Inc.
Address
5403 Betsy Ross Drive
Santa Clara, CA 95054
USA
Country
United States of America
Secondary sponsor category [1] 315074 0
Commercial sector/Industry
Name [1] 315074 0
Australian Healthcare Solutions Pty Ltd
Address [1] 315074 0
Level 1 / 424 Burke Road
Camberwell, Victoria 3124
Country [1] 315074 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312553 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 312553 0
Austin Health
Austin Hospital
145 Studley Road
Heidelberg, VIC 3084
Ethics committee country [1] 312553 0
Australia
Date submitted for ethics approval [1] 312553 0
18/11/2022
Approval date [1] 312553 0
10/05/2023
Ethics approval number [1] 312553 0
Ethics committee name [2] 312554 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [2] 312554 0
Royal Melbourne Hospital
300 Royal Parade
Parkville, VIC 3050
Ethics committee country [2] 312554 0
Australia
Date submitted for ethics approval [2] 312554 0
29/03/2023
Approval date [2] 312554 0
29/03/2023
Ethics approval number [2] 312554 0

Summary
Brief summary
The Shockwave Medical Mini C Flex Feasibility Study is to assess the safety, efficacy and feasibility of the Shockwave Medical Mini C Flex IVL System for the treatment of heavily calcified and stenotic coronary arteries.
Participants in this study will have a pre and post procedure pathway that is similar to the conventional method of managing / treating these coronary artery blockages. The difference of participation in the study will be the use of the Shockwave Medical Mini C Flex IVL catheter to treat the calcified plaque within the coronary artery. The subject will then progress to normal destination therapy.
Subjects who chose to participate will be followed at discharge, 30 days, 6 months and 12 months following their procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125066 0
Dr James Spratt
Address 125066 0
St. George's Hospital, Blackshaw Road, London, SW17 0QT
Country 125066 0
United Kingdom
Phone 125066 0
+44 7816615315
Fax 125066 0
Email 125066 0
james.spratt@nhs.net
Contact person for public queries
Name 125067 0
Mr Randee Randoll
Address 125067 0
Shockwave Medical Inc. 5403 Betsy Ross Drive Santa Clara, CA 95054 USA
Country 125067 0
United States of America
Phone 125067 0
+14085777856
Fax 125067 0
Email 125067 0
rrandoll@shockwavemedical.com
Contact person for scientific queries
Name 125068 0
Ms Randee Randoll
Address 125068 0
Shockwave Medical Inc.
5403 Betsy Ross Drive
Santa Clara, CA 95054
USA
Country 125068 0
United States of America
Phone 125068 0
+14085777856
Fax 125068 0
Email 125068 0
rrandoll@shockwavemedical.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is only being published as a batch - not on an individual basis


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
No additional documents have been identified.