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Trial registered on ANZCTR


Registration number
ACTRN12620000086965
Ethics application status
Approved
Date submitted
4/12/2019
Date registered
3/02/2020
Date last updated
3/02/2020
Date data sharing statement initially provided
3/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
BASIL Study: A randomised comparison study on the treatment of calcified (hard and concrete-like) coronary artery using the conventional balloon angioplasty prior stenting versus the use of Shockwave Intravascular Lithotripsy (S-IVL) prior to stenting.
Scientific title
Balloon Angioplasty versus Shockwave Intravascular Lithotripsy for calcified coronary stenosis
Secondary ID [1] 299876 0
Protocol Reference: SIVL-2019
Universal Trial Number (UTN)
U1111-1244-9170
Trial acronym
BASIL Study
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 315463 0
Calcified Coronary Arteries 315464 0
Coronary Disease 315465 0
Heart Diseases 315466 0
Cardiovascular Diseases 315467 0
Arteriosclerosis 315468 0
Arterial Occlusive Diseases 315469 0
Myocardial Ischemia 315470 0
Vascular Diseases 315471 0
Condition category
Condition code
Cardiovascular 313807 313807 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Balloon Angioplasty versus Shockwave Intravascular Lithotripsy (S-IVL). Participants enrolled into this Clinical Research will be derived from the general interventional
cardiology population. Patients meeting all clinical inclusion criteria and undergoing coronary angiography who are found to have significant calcified coronary stenosis will be eligible to participate in this study at the time of their coronary stent implantation procedure in the cardiac catheter laboratory. The Interventional Cardiologist will deliver the intervention procedure during the patient's scheduled percutaneous coronary intervention (PCI) with the use of either percutaneous coronary angioplasty with coronary stent implantation or with the use of Shockwave Intravascular Lithotripsy (S-IVL) percutaneous coronary angioplasty with coronary stent implantation as per randomisation allocation. Post procedure and hospital discharge monitoring will be performed in the Cardiovascular Unit and or at the Cardiology Ward. Telephone follow-up will be performed 30 days following hospital discharge.

A) a brief description of the procedures, including how they differ,

Calcified coronary lesions pose challenges for percutaneous coronary intervention (PCI). Aggressive balloon dilatation for lesion preparation may result in unnecessary vessel dissection and vessel trauma. Stent delivery is often more difficult and not uncommonly calcification results in stent under-expansion with reduced final lumen diameter (FLD). There is an association between heavily calcified lesions and subsequent target lesion failure (TLF) and target vessel failure (TVF)

Several methods of lesion preparation have been utilised in the past: directional atherectomy, laser atherectomy and transluminal extraction catheters. These have become obsolete. The conventional contemporary lesion preparation is the use of rotational or orbital atherectomy utilizing high-speed rotating burrs or the use of various cutting and scoring balloons designed to disrupt lesion architecture. Whereas there is limited direct clinical outcome benefit for these devices, their ability to enhance stent delivery and optimize expansion and reduce procedural risk indirectly translates into better outcomes.

Calcified coronary lesions often cause suboptimal stent expansion, which is one of the greatest predictors of adverse outcomes such as stent thrombosis and restenosis. Shockwave intravascular lithotripsy (S-IVL; Shockwave Medical, Inc) is a recently approved technique used in the treatment of heavily calcified coronary lesions.

Shockwave Intravascular lithotripsy (S-IVL) was recently developed for use in coronary lesions. Lithotripsy is delivered when emitters within a delivery balloon generate sonic pressure waves selectively fracturing calcium within the vessel wall resulting in better stent delivery and expansion. Shockwave C2 catheter gained European CE marking in May 2017. It has been proven to be safe with no excess procedural or 30-day negative clinical outcome measures.

B) any physical or informational materials used, including a description of any device(s) used:

All patients undergoing coronary angiography will be screened for their BASIL Study eligibility and those that have not met any of the clinical exclusion criteria will be invited to participate and will be given the New Zealand Health and Disability Ethics Committee (NZ HDEC) approved participant information sheet and consent form ahead of time prior to their scheduled coronary angiogram procedure. If the patient agrees to participate, clinical study participant information sheet and consent form must be signed and completed by the patient and the BASIL Study Team as delegated by the Principal Investigator. A copy of the completed informed consent form must be provided to the patient and a copy kept on the patient’s medical records including the documentation of the consent process. All patients must be given the opportunity to ask questions about the study and must be given sufficient time to decide to participate in the study or not. The patient is to be made aware that their participation in the study is voluntary and that they may withdraw from the study at any time, without giving specific reason for doing so. The patient must also be informed that withdrawal from the study will not affect their future treatment. The investigator is responsible for the achievement of written consent from the patient before they are included in the study. All patients must provide informed consent in accordance with the NZ HDEC requirements, using an EC-approved informed consent form. Confirmation of patient enrolment status (randomised/included or not randomised/not included) to the BASIL Study following angiographic screening procedures will be given to patients who have signed the participant information sheet and consent form following their coronary angiography procedure and copies filed to subject’s medical file.

Shockwave intravascular lithotripsy (S-IVL) manufactured by Shockwave Medical, Inc is a recently approved technique used in the treatment of heavily calcified coronary lesions.

C) the approximate duration of the procedure(s).

A diagnostic angiogram would normally take from 30 up to 60 minutes. The use of Shockwave Coronary Intravascular Lithotripsy (S-IVL) may take from to 30 to 45 minutes. The total hours involved in percutaneous coronary intervention (PCI) normally takes 90 minutes and up to two hours, although it can take longer.
Intervention code [1] 316263 0
Treatment: Devices
Comparator / control treatment
Pre-dilatation with conventional balloon angioplasty for the treatment of heavily calcified coronary stenoses prior to stent implantation.
Control group
Active

Outcomes
Primary outcome [1] 322175 0
Angiographic success is defined as ability to pre-dilate target vessel to facilitate stent delivery without bailout techniques or cross over and no intra-procedural complications.

Classification of procedural complications during intervention as observed during angiography:

1. vessel perforation
2. abrupt vessel occlusion
3. major dissection (type D to F)
4. persistent slow flow
5. no flow (TIMI equals zero)
5. cardiac death

Angiographic success is assessed by measurement of mean lesion diameter stenosis less than 20 per cent after a successful stent deployment and balloon post dilation in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed and documented in the subject's clinical notes by the physician, without the occurrence of vessel perforation, no abrupt vessel occlusion, no major dissection (type D to F), absence of persistent slow flow or no flow and no cardiac death event. Data will be documented in the angiographic procedure report and collected in the project's case report form.

Bailout is at the operator's discretion when the randomised technique is felt to be inadequate in preparing the calcified lesion prior to stent implantation.
Timepoint [1] 322175 0
Angiographic success as assessed during percutaneous coronary intervention.
Primary outcome [2] 322211 0
Clinical success is defined as no procedural related major adverse events: Myocardial Infarction (MI) with type 4A MI (peri-procedural), stroke, TVR/TLF (revascularization of target vessel inclusive of target lesion after completion of index procedure), death prior to discharge from hospital.

Clinical outcome is assessed following post coronary stenting procedure time point to hospital discharge as evaluated and documented in the subject's clinical notes by the physician, without the occurrence of the following major adverse events:

Classification of procedural complications:

1. No Myocardial Infarction (MI) with type 4A MI (peri-procedural)
2. No stroke
3. No target vessel revascularisation (TVR)
4. No target lesion failure (TLF) leading to revascularization of target lesion.

These will be captured and recorded in the follow-up clinical notes and in the project's case report form.
Timepoint [2] 322211 0
Intra-procedure, post procedure hospitalisation to discharge
Secondary outcome [1] 377571 0
Death
Timepoint [1] 377571 0
30 days
Secondary outcome [2] 378274 0
Target vessel failure. This will be assessed by ischemia-driven revascularization of the target vessel, Myocardial Infarction related to the target vessel or death related to the target vessel.
Ischemia- driven revascularisation of the target vessel will be based in once of the following abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers.
Timepoint [2] 378274 0
30 days
Secondary outcome [3] 378275 0
Target lesion failure. This will be assessed by any ischemia-driven revascularization of the target lesion, Myocardial Infarction related to the target lesion, or (cardiac) death related to the target lesion. This will be determined from coronary angiogram.

Ischemia- driven revascularisation of the target lesion will be based in once of the following abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers.
Timepoint [3] 378275 0
30 days
Secondary outcome [4] 378276 0
Myocardial infarction. As per 4th universal definition of type 1 myocardial infarction.

Detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL and with at least one of the following:
•Symptoms of acute myocardial ischaemia;
•New ischaemic ECG changes;
•Development of pathological Q waves;
•Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology;
•Identification of a coronary thrombus by angiography including intracoronary imaging or by autopsy

This will be determined from medical records including reports of blood analysis, and electrocardiogram (ECG).

Timepoint [4] 378276 0
30 days
Secondary outcome [5] 378868 0
Cost analysis:

Total equipment used as documented by catherization laboratory staff during procedure eg. number of catheters, coronary guidewires, stents, balloons.
Timepoint [5] 378868 0
During index procedure
Secondary outcome [6] 378869 0
Total procedure time. This will be measured by an electronic timer in the catheterisation laboratory from time of randomisation to end of procedure. This will be documented in the procedure time log.
Timepoint [6] 378869 0
From randomisation till end of procedure
Secondary outcome [7] 378870 0
Length of hospitalisation. This will be documented on hospital records.
Timepoint [7] 378870 0
From day of procedure till discharge

Eligibility
Key inclusion criteria
Patients undergoing coronary angiography who is found to have significant calcified coronary stenosis are eligible. Coronary artery stenosis is defined by either qualitative or quantitative coronary angiography with more than 60% diameter stenosis in equal or greater than 2.5 mm reference vessel diameter of coronary artery with severe calcification.

Assessment by intravascular ultrasound (IVUS) with presence of greater than 270° arc of calcification at worst point in lesion. If IVUS cannot be delivered, inclusion can be made by angiographic appearance of heavy calcification.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participant is currently enrolled in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.

• Participant is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential).

• Participant experienced an acute ST Elevation Myocardial Infarction (STEMI).

• Patient has contraindication to taking dual antiplatelet therapy for a minimum of 6 months.

• Patients in cardiogenic shock.

• Concomitant use of other calcium modification devices prior to randomisation i.e atherectomy, cutting balloons etc.

• Chronic total occlusion

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)
Randomisation by random number generator 1:1. Allocation will be done by concealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be used by using coin-tossing procedure.

Cohort A: Shockwave IVL plus PCI

All enrolled patients will receive S-IVL treatment prior to coronary stent placement. Low profile balloon pre-dilation to deliver S-IVL allowed. Cross over or bailout techniques (cutting-balloon, rotational atherectomy) allowed for patient safety.

Cohort B: Balloon angioplasty plus PCI

All enrolled patients will receive conventional balloon angioplasty pre-dilatation prior to coronary stent placement. Cross over or bailout techniques allowed for patient safety. Default bailout option is to be shockwave intravascular lithotripsy. Exception is if the operator feels a balloon cannot be delivered.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cross over or bailout techniques allowed for patient safety. Default bailout option is to be shockwave intravascular lithotripsy. Exception is if the operator feels a balloon cannot be delivered.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be used for the baseline characteristics of the population. Continuous variables will be reported as mean (plus or minus) standard deviation (SD) or median (interquartile range). Categorical variables will be reported as frequencies or percentages. Comparisons between categorical variables will be made either using chi square or Fisher exact test. Continuous data will be compared using the Student’s t-test or Mann-Whitney U test. Two sided p values of less than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22163 0
New Zealand
State/province [1] 22163 0
Auckland

Funding & Sponsors
Funding source category [1] 304336 0
Commercial sector/Industry
Name [1] 304336 0
Shockwave Medical
Address [1] 304336 0
5403 Betsy Ross Dr., Santa Clara, CA 95054, USA
Country [1] 304336 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Scockwave Medical
Address
5403 Betsy Ross Dr., Santa Clara, CA 95054, USA
Country
United States of America
Secondary sponsor category [1] 304584 0
None
Name [1] 304584 0
Address [1] 304584 0
Country [1] 304584 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304787 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 304787 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 304787 0
New Zealand
Date submitted for ethics approval [1] 304787 0
17/09/2019
Approval date [1] 304787 0
15/11/2019
Ethics approval number [1] 304787 0
19/NTB/161

Summary
Brief summary
The objective of this study is to compare the performance of the Shockwave Coronary Intravascular Lithotripsy (S-IVL) versus pre-dilatation with conventional balloon angioplasty for the treatment of heavily calcified coronary stenoses prior to stent implantation.

The study will be conducted at a single site in North Shore Hospital in Auckland, and the participants will be followed up for 30 days post procedure.

Patients of at least 18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main stem, left anterior descending, left circumflex or right coronary artery will be eligible to enrol in the study. The patient will be randomised in the catheterization laboratory after diagnostic angiography is reviewed and the lesions deemed suitable for either procedural approach.

Procedural, in hospital and 30-day outcome measures will be collected. 30 Day follow-up will be performed via telephone follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98202 0
Dr Seif El-Jack
Address 98202 0
Cardiovascular Unit, Lakeview Cardiology Centre, Level 1
North Shore Hospital, 124 Shakespeare Road
Takapuna, 0622 Auckland 0622
Country 98202 0
New Zealand
Phone 98202 0
+64 09 4868920
Fax 98202 0
+64 09 4884624
Email 98202 0
Seif.ElJack@waitematadhb.govt.nz
Contact person for public queries
Name 98203 0
Mr Hector Gonzales
Address 98203 0
Cardiovascular Unit, Lakeview Cardiology Centre, Level 1
North Shore Hospital, 124 Shakespeare Road
Takapuna, 0622 Auckland 0622
Country 98203 0
New Zealand
Phone 98203 0
+64 094884624
Fax 98203 0
+64 09 4884624
Email 98203 0
hector.gonzales@waitematadhb.govt.nz
Contact person for scientific queries
Name 98204 0
Dr Bernard Wong
Address 98204 0
Cardiovascular Unit, Lakeview Cardiology Centre, Level 1
North Shore Hospital, 124 Shakespeare Road
Takapuna, 0622 Auckland 0622
Country 98204 0
New Zealand
Phone 98204 0
+64 21 2034975
Fax 98204 0
+64 09 4884624
Email 98204 0
Bernard.Wong@waitematadhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not applicable
What supporting documents are/will be available?
No other documents available
Summary results
No Results