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ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, the SONAR Trial (SONAR)

Primary Purpose

Calcified Atheroma, Coronary Artery Disease

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Rotablation of shockwave

About this trial

This is an interventional other trial for Calcified Atheroma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

University Hopsitals LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Rotablation

Shockwave IVL

Arm Description

Use of rotational atherectomy first-line if NC balloon does not fully open

Use of Shockwave IVLS first-line if NC balloon does not fully open

Outcomes

Primary Outcome Measures

Difference in peri-procedural myocardial infarction (Type 4a)

Measurements of HS Troponine T at 8hrs, 16hrs and 24 hrs post PCI

Secondary Outcome Measures

Procedural differences (technical and procedural success, procedural characteristics and costs).

procedural characteristics

Difference in change in IMR between the two groups.

measurement of IMR before and after PCI

Clinical outcomes at 30-days and 1 year.

clinical outcomes (Major adverse clinical events, including MI, TLR and cardiac death)

IMR change post-PCI in calcified lesions

measurement of IMR before and after PCI

Peri-procedural myocardial injury incidence

Measurements of HS Troponine T at 8hrs, 16hrs and 24 hrs post PCI

Full Information

NCT ID

NCT05208749

First Posted

December 8, 2021

Last Updated

June 10, 2022

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Ziekenhuis Oost-Limburg, University Hospital, Ghent, Universitair Ziekenhuis Brussel, Ziekenhuis Netwerk Antwerpen (ZNA), Imelda Hospital, Bonheiden, AZ St- Jan Brugge, Centre Hospitalier Universitaire Saint Pierre, Hôpital Jolimont

1. Study Identification

Unique Protocol Identification Number

NCT05208749

Brief Title

ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, the SONAR Trial

Acronym

SONAR

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 4, 2022 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Calcified Atheroma, Coronary Artery Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rotablation

Arm Type

Active Comparator

Arm Description

Use of rotational atherectomy first-line if NC balloon does not fully open

Arm Title

Shockwave IVL

Arm Type

Active Comparator

Arm Description

Use of Shockwave IVLS first-line if NC balloon does not fully open

Intervention Type

Device

Intervention Name(s)

Rotablation of shockwave

Intervention Description

Patients will be randomized to treatment with rotablation or shockwave

Primary Outcome Measure Information:

Title

Difference in peri-procedural myocardial infarction (Type 4a)

Description

Measurements of HS Troponine T at 8hrs, 16hrs and 24 hrs post PCI

Time Frame

within 24 hours of index PCI

Secondary Outcome Measure Information:

Title

Procedural differences (technical and procedural success, procedural characteristics and costs).

Description

procedural characteristics

Time Frame

periprocedural

Title

Difference in change in IMR between the two groups.

Description

measurement of IMR before and after PCI

Time Frame

periprocedural

Title

Clinical outcomes at 30-days and 1 year.

Description

clinical outcomes (Major adverse clinical events, including MI, TLR and cardiac death)

Time Frame

1 year

Title

IMR change post-PCI in calcified lesions

Description

measurement of IMR before and after PCI

Time Frame

periprocedural

Title

Peri-procedural myocardial injury incidence

Description

Measurements of HS Troponine T at 8hrs, 16hrs and 24 hrs post PCI

Time Frame

periprocedural

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Facility Information:

Facility Name

University Hopsitals Leuven

City

Leuven

State/Province

Brabant

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Johan Bennett, MD PhD

Phone

3216342466

sic@uzleuven.be

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, the SONAR Trial

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