Calcified AtheromaSONARNCT05208749
ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, the SONAR Trial
A study testing Rotablation of shockwave in people with Calcified Atheroma and Coronary Artery Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Percutaneous coronary interventions (PCI) is intended to relieve myocardial ischemia by improving blood flow in the epicardial coronary arteries. However, the efficacy of PCI may be compromised by incidental microvascular obstruction and peri-procedural myocardial infarction (PPMI), which occurs in about 10-15% of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcified Atheroma, Coronary Artery Disease
- What is being tested?
- Rotablation of shockwave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Feb 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 18 years.
- The subject has stable or unstable angina pectoris, or a positive functional study for ischemia.
- The subject is eligible for PCI.
- The subject gives consent prior to study inclusion.
- The subject has a calcified lesion that does not dilated fully after balloon angioplasty at 16atm with a ≥2.5mm non-compliant balloon.
- The calcified lesion has a 50-90% diameter stenosis by angiographic assessment.
Who cannot join
- Previous and/or planned brachytherapy of target vessel.
- Pregnant and/or breast-feeding females or females who intend to become pregnant.
- Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
- Patients who previously participated in this study.
- Subject has experienced an acute myocardial infarction 72 hours prior to the index procedure, as defined either by the presence of a new Q-wave in 2 or more contiguous leads, or by a CK greater than two times site upper reference limit (URL) with presence of CK-MB greater than the site URL.
- The subject has suffered a stroke or transient ischemic neurological attack or cerebrovascular accident within the past six months, or has any known intracranial mass, arteriovenous malformation, aneurysm or other intracranial pathology.
Show all 12Show fewer
- The subject has experienced a significant gastrointestinal or genitourinary bleed within the past six months, or has had any active bleeding within two months.
- Planned revascularization of target vessel within 1 year after index procedure.
- Lesions not ideal for Shockwave treatment:
- Longer than 40mm.
- The target vessel contains intraluminal thrombus.
- The subject has had a prior stent in the target lesion, including a 5mm zone proximal and distal to the lesion.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hopsitals Leuven
Leuven, Brabant, 3000
Johan Bennett, MD PhD, 3216342466, sic@uzleuven.be
About this study
Official title: A Randomized Controlled Trial Comparing Rates of Peri-procedural Myocardial Infarction After Intravascular Ultrasound and Rotational Atherectomy in Patients With Calcified Coronary Artery Lesions
Percutaneous coronary interventions (PCI) is intended to relieve myocardial ischemia by improving blood flow in the epicardial coronary arteries. However, the efficacy of PCI may be compromised by incidental microvascular obstruction and peri-procedural myocardial infarction (PPMI), which occurs in about 10-15% of cases and is associated with increased rates of major adverse cardiovascular events (MACE). The mechanism of PPMI is thought to be related to side branch occlusion, coronary artery dissection and acute microvascular damage caused by embolization of plaque debris during the PCI and is more frequently seen in calcified coronary artery disease. Calcium modification by rotational atherectomy (RA) results in peri-procedural myocardial infarction in 24% of cases and myocardial injury in 70% of cases. The Shockwave coronary intravascular lithotripsy (IVL) balloon catheter emits sonic pressure waves in a circumferential field causing the selective fracture of calcium, altering vessel compliance and permitting further expansion of the vessel wall. This provides a potentially safer alternative to other calcium-modifying devices since there is a low risk of dissection and perforation. It is also proposed that this IVL device reduces the risk of atheromatous embolization, which would reduce the risk of PPMI and microvascular dysfunction. The SONAR Trial is a pilot study measuring peri-procedural myocardial injury, PPMI and microvascular dysfunction in patients (with calcified coronary artery lesions not responding to usual balloon dilatation) randomized to RA or Shockwave IVL. The primary outcome is peri-procedural myocardial infarction. Secondary outcomes include peri-procedural myocardial injury, acute microvascular dysfunction, procedural success, and procedural costs.
Read the detailed description
In this multicentre, prospective, randomized-controlled open label pilot study the investigators will measure rates of peri-procedural myocardial infarction and changes in microvascular function after PCI in 170 patients (85 per arm) treated with Shockwave intravascular lithotripsy (IVL) versus RA. Patients with moderately and/or severely calcified coronary lesions, which are equally suitable for IVL and RA and do not dilate fully (100%) with an appropriately sized non-compliant balloon at 16 atmospheres, will be recruited. The calcified lesion must be suitable for both IVL and RA and the operator believes that either IVL or RA could be used. The primary outcome will be difference in the rate of peri-procedural myocardial infarction (Type 4a of the universal Definition of Myocardial Infarction). Peri-procedural myocardial injury and infarction will be defined by an increase in high-sensitivity Troponin T according to the Fourth Universal Definition of Myocardial Infarction,15 while microvascular dysfunction will be defined by an Index of Microcirculatory Resistance (IMR) of ≥25.16 Patients will undergo study-related clinical follow up at 30 days and 12 months.
- Conditions
- Calcified Atheroma, Coronary Artery Disease
- Being tested
- Rotablation of shockwave
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotablation of shockwaveDevice
Patients will be randomized to treatment with rotablation or shockwave
| Study group | Role | What they receive |
|---|---|---|
| Rotablation | Active comparator | Use of rotational atherectomy first-line if NC balloon does not fully open Receives: Device: Rotablation of shockwave |
| Shockwave IVL | Active comparator | Use of Shockwave IVLS first-line if NC balloon does not fully open Receives: Device: Rotablation of shockwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in peri-procedural myocardial infarction (Type 4a)
Measurements of HS Troponine T at 8hrs, 16hrs and 24 hrs post PCI
Measured: within 24 hours of index PCI
Secondary outcomes (5)
Procedural differences (technical and procedural success, procedural characteristics and costs).
procedural characteristics
Measured: periprocedural
Difference in change in IMR between the two groups.
measurement of IMR before and after PCI
Measured: periprocedural
Clinical outcomes at 30-days and 1 year.
clinical outcomes (Major adverse clinical events, including MI, TLR and cardiac death)
Measured: 1 year
IMR change post-PCI in calcified lesions
measurement of IMR before and after PCI
Measured: periprocedural
Peri-procedural myocardial injury incidence
Measurements of HS Troponine T at 8hrs, 16hrs and 24 hrs post PCI
Measured: periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start4 Feb 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Calcified AtheromaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, University Hospital, Ghent, Universitair Ziekenhuis Brussel, Ziekenhuis Netwerk Antwerpen (ZNA), Imelda Hospital, Bonheiden, AZ Sint-Lucas Brugge, Centre Hospitalier Universitaire Saint Pierre, Hôpital Jolimont
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208749
- Sponsor's protocol ID
- S64676
- Acronym
- SONAR
- Status last verified
- Jul 2024
- First submitted
- 8 Dec 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bennett J, McCutcheon K, Ameloot K, Vanhaverbeke M, Lesizza P, Castaldi G, Adriaenssens T, Minten L, Palmers PJ, de Hemptinne Q, de Wilde W, Ungureanu C, Vandeloo B, Colletti G, Coussement P, Van Mieghem NM, Dens J. ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions: Design and rationale of the SONAR trial. Cardiovasc Revasc Med. 2024 Mar;60:82-86. doi: 10.1016/j.carrev.2023.08.019. Epub 2023 Sep 9.
PubMed 37714726
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Rates of Peri-procedural Myocardial Infarction After Intravascular Ultrasound and Rotational Atherectomy in Patients With Calcified Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT05208749
- Acronym / sponsor ID
- SONAR / S64676
- Conditions
- Calcified Atheroma, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, University Hospital, Ghent, Universitair Ziekenhuis Brussel, Ziekenhuis Netwerk Antwerpen (ZNA), Imelda Hospital, Bonheiden, AZ Sint-Lucas Brugge, Centre Hospitalier Universitaire Saint Pierre, Hôpital Jolimont
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Percutaneous coronary interventions (PCI) is intended to relieve myocardial ischemia by improving blood flow in the epicardial coronary arteries. However, the efficacy of PCI may be compromised by incidental microvascular obstruction and peri-procedural myocardial infarction (PPMI), which occurs in about 10-15% of cases and is associated with increased rates of major adverse cardiovascular events (MACE). The mechanism of PPMI is thought to be related to side branch occlusion, coronary artery dissection and acute microvascular damage caused by embolization of plaque debris during the PCI and is more frequently seen in calcified coronary artery disease. Calcium modification by rotational atherectomy (RA) results in peri-procedural myocardial infarction in 24% of cases and myocardial injury in 70% of cases. The Shockwave coronary intravascular lithotripsy (IVL) balloon catheter emits sonic pressure waves in a circumferential field causing the selective fracture of calcium, altering vessel compliance and permitting further expansion of the vessel wall. This provides a potentially safer alternative to other calcium-modifying devices since there is a low risk of dissection and perforation. It is also proposed that this IVL device reduces the risk of atheromatous embolization, which would reduce the risk of PPMI and microvascular dysfunction. The SONAR Trial is a pilot study measuring peri-procedural myocardial injury, PPMI and microvascular dysfunction in patients (with calcified coronary artery lesions not responding to usual balloon dilatation) randomized to RA or Shockwave IVL. The primary outcome is peri-procedural myocardial infarction. Secondary outcomes include peri-procedural myocardial injury, acute microvascular dysfunction, procedural success, and procedural costs.
Detailed description
In this multicentre, prospective, randomized-controlled open label pilot study the investigators will measure rates of peri-procedural myocardial infarction and changes in microvascular function after PCI in 170 patients (85 per arm) treated with Shockwave intravascular lithotripsy (IVL) versus RA. Patients with moderately and/or severely calcified coronary lesions, which are equally suitable for IVL and RA and do not dilate fully (100%) with an appropriately sized non-compliant balloon at 16 atmospheres, will be recruited. The calcified lesion must be suitable for both IVL and RA and the operator believes that either IVL or RA could be used. The primary outcome will be difference in the rate of peri-procedural myocardial infarction (Type 4a of the universal Definition of Myocardial Infarction). Peri-procedural myocardial injury and infarction will be defined by an increase in high-sensitivity Troponin T according to the Fourth Universal Definition of Myocardial Infarction,15 while microvascular dysfunction will be defined by an Index of Microcirculatory Resistance (IMR) of ≥25.16 Patients will undergo study-related clinical follow up at 30 days and 12 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotablation | Active comparator | Device: Rotablation of shockwaveUse of rotational atherectomy first-line if NC balloon does not fully open |
| Shockwave IVL | Active comparator | Device: Rotablation of shockwaveUse of Shockwave IVLS first-line if NC balloon does not fully open |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient older than 18 years.
- The subject has stable or unstable angina pectoris, or a positive functional study for ischemia.
- The subject is eligible for PCI.
- The subject gives consent prior to study inclusion.
- The subject has a calcified lesion that does not dilated fully after balloon angioplasty at 16atm with a ≥2.5mm non-compliant balloon.
Key exclusion criteria (12 listed)
- Previous and/or planned brachytherapy of target vessel.
- Pregnant and/or breast-feeding females or females who intend to become pregnant.
- Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
- Patients who previously participated in this study.
- Subject has experienced an acute myocardial infarction 72 hours prior to the index procedure, as defined either by the presence of a new Q-wave in 2 or more contiguous leads, or by a CK greater than two times site upper reference limit (URL) with presence of CK-MB greater than the site URL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotablation of shockwavePatients will be randomized to treatment with rotablation or shockwave | Device | Rotablation, Shockwave IVL |
Primary outcome
Difference in peri-procedural myocardial infarction (Type 4a)
Time frame: within 24 hours of index PCI
Measurements of HS Troponine T at 8hrs, 16hrs and 24 hrs post PCI
5 secondary outcomes
Procedural differences (technical and procedural success, procedural characteristics and costs).
Time frame: periprocedural
Difference in change in IMR between the two groups.
Time frame: periprocedural
Clinical outcomes at 30-days and 1 year.
Time frame: 1 year
IMR change post-PCI in calcified lesions
Time frame: periprocedural
Peri-procedural myocardial injury incidence
Time frame: periprocedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 37714726Bennett J, McCutcheon K, Ameloot K, Vanhaverbeke M, Lesizza P, Castaldi G, Adriaenssens T, Minten L, Palmers PJ, de Hemptinne Q, de Wilde W, Ungureanu C, Vandeloo B, Colletti G, Coussement P, Van Mieghem NM, Dens J. ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions: Design and rationale of the SONAR trial. Cardiovasc Revasc Med. 2024 Mar;60:82-86. doi: 10.1016/j.carrev.2023.08.019. Epub 2023 Sep 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotablation of shockwave in people with Calcified Atheroma and Coronary Artery Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in peri-procedural myocardial infarction (Type 4a) (time frame: within 24 hours of index PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05208749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.