Prospective, Multicenter, Single-Arm Study of the SWM-1234 in Calcified Coronary Arteries (Disrupt CAD IV Study - Japan)

Shockwave Medical, Inc.8 sites in 1 country72 target enrollmentNovember 6, 2019

ConditionsCoronary Artery Disease Myocardial Infarction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Shockwave Medical, Inc.
Enrollment: 72
Locations: 8
Primary Endpoint: Percentage of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study design is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting.

Detailed Description

Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention. Approximately 72 subjects at 8 sites in Japan will be enrolled. Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.

Registry

clinicaltrials.gov

Start Date

November 6, 2019

End Date

March 25, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shockwave Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is ≥18 years of age
•Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
•For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure (note: if both labs are drawn both must be normal)
•For patients with stable ischemic heart disease, biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath.
•If drawn prior to the procedure, biomarkers (troponin or CK- MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the index procedure (note: if both labs are drawn, both must be normal)
•If biomarkers are drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analyzed prior to enrollment.
•Left ventricular ejection fraction \> 25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criteria; may be assessed at time of index procedure)
•Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
•Lesions in non-target vessels requiring PCI may be treated either:
•\>30 days prior to the study procedure if the procedure was unsuccessful or complicated; or

Exclusion Criteria

•Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
•Subject is a member of a vulnerable population including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
•Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
•Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
•Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months
•Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
•Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK- MB greater than 1 times the local laboratory's upper limit of normal
•New York Heart Association (NYHA) class III or IV heart failure
•Renal failure with serum creatinine \>2.5 mg/dL, or chronic dialysis
•History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit

Outcomes

Primary Outcomes

Percentage of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure

Time Frame: Within 30 days of index procedure

The primary safety endpoint was freedom from major adverse cardiac events (MACE) at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Intent To Treat (ITT) population.

Percentage of Subjects With Procedural Success

Time Frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure

The primary effectiveness endpoint was Procedural Success defined as stent delivery with a residual in-stent stenosis \<50% (core laboratory assessed) and without in-hospital MACE

Secondary Outcomes

Number of Participants With Device Crossing Success(At end of procedure, with a mean total procedure time of 62.5 minutes)
Number of Participants With Angiographic Success (Residual Stenosis <50%)(At end of procedure, with a mean total procedure time of 62.5 minutes)
Number of Participants With Procedural Success (Residual Stenosis <=30%)(12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure)
Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 24 Months(within 24 months of index procedure)
Non-Procedural MI at 30 Days(within 30 days of index procedure)
Non-Procedural MI at 6 Months(within 6 months of index procedure)
Non-Procedural MI at 12 Months(within 12 months of index procedure)
Non-Procedural MI at 24 Months(within 24 months of index procedure)
Number of Participants With Angiographic Success (Residual Stenosis <=30%)(At end of procedure, with a mean total procedure time of 62.5 minutes)
Number of Participants With Serious Angiographic Complications(At end of procedure, with a mean total procedure time of 62.5 minutes)
MACE Rate at 6 Months(within 6 months of index procedure)
MACE Rate at 12 Months(within 12 months of index procedure)
MACE Rate at 24 Months(within 24 months of index procedure)
Target Lesion Failure (TLF) at 30 Days(Within 30 days of index procedure)
Target Lesion Failure (TLF) at 6 Months(Within 6 months of index procedure)
Target Lesion Failure (TLF) at 12 Months(Within 12 months of index procedure)
Target Lesion Failure (TLF) at 24 Months(Within 24 months of index procedure)
All-Cause Death at 12 Months(within 12 months of procedure)
All-Cause Death at 24 Months(within 24 months of procedure)
Myocardial Infarction (MI) at 30 Days(within 30 days of index procedure)
Myocardial Infarction (MI) at 6 Months(Within 6 months of index procedure)
Myocardial Infarction (MI) at 12 Months(Within 12 months of index procedure)
Myocardial Infarction (MI) at 24 Months(Within 24 months of index procedure)
Myocardial Infarction Attributable to Target Vessel (TV-MI) at 30 Days(within 30 days of index procedure)
Myocardial Infarction Attributable to Target Vessel (TV-MI) at 6 Months(Within 6 month of index procedure)
Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 30 Days(within 30 days of index procedure)
Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 6 Months(within 6 months of index procedure)
Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 12 Months(within 12 months of index procedure)
All-Cause Death at 30 Days(Within 30 days from index procedure)
Ischemia-driven Target Vessel Revascularization (ID-TVR) at 24 Months(within 24 months of index procedure)
Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 24 Months(within 24 months of index procedure)
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 30 Days(within 30 days of index procedure)
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 6 Months(within 6 months of index procedure)
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 12 Months(within 12 months of index procedure)
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 24 Months(within 24 months of index procedure)
Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 30 Days(within 30 days of index procedure)
Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 6 Months(within 6 months of index procedure)
Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 12 Months(within 12 months of index procedure)
Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 24 Months(within 24 months of index procedure)
Procedural MI at 30 Days(within 30 days of index procedure)
Procedural MI at 6 Months(within 6 months of index procedure)
All-Cause Death at 6 Months(within 6 months of index procedure)
Myocardial Infarction Attributable to Target Vessel (TV-MI) at 24 Months(Within 24 months of index procedure)
Procedural MI at 12 Months(within 12 months of index procedure)
Procedural MI at 24 Months(within 24 months of index procedure)
Myocardial Infarction Attributable to Target Vessel (TV-MI) at 12 Months(Within 12 months of index procedure)
Stent Thrombosis at 30 Days(Within 30 days of index procedure)
Stent Thrombosis at 6 Months(within 6 months of index procedure)
Stent Thrombosis at 12 Months(within 12 months of index procedure)
Stent Thrombosis at 24 Months(within 24 months of index procedure)
All Revascularizations at 30 Days(within 30 days of index procedure)
All Revascularizations at 6 Months(within 6 months of index procedure)
All Revascularizations at 12 Months(within 12 months of index procedure)
All Revascularizations at 24 Months(within 24 months of index procedure)
Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 30 Days(within 30 days of index procedure)
Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 6 Months(within 6 months of index procedure)
Ischemia-driven Target Vessel Revascularization (ID-TVR) at 12 Months(within 12 months of index procedure)
Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 30 Days(within 30 days of index procedure)
Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 6 Months(within 6 months of index procedure)
Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 12 Months(within 12 months of index procedure)
Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 24 Months(within 24 months of index procedure)
Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 30 Days(within 30 days of index procedure)
Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 6 Months(within 6 months of index procedure)
Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 12 Months(within 12 months of index procedure)