AzTrials
AzTrials

Coronary Artery DiseaseNCT04151628

Disrupt CAD IV With the Shockwave Coronary IVL System

A study testing Lithotripsy in people with Coronary Artery Disease and Myocardial Infarction, run by Shockwave Medical, Inc. at 8 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lithotripsy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
8 sitesJapan
Study dates
6 Nov 2019to 25 Mar 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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.
Show all 23Show fewer
  • 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
  • >24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis <30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and with no post-procedure biomarker elevation
  • >normal; or
  • >30 days after the study procedure
  • Angiographic Inclusion Criteria
  • The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
  • Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with:
  • Stenosis of ≥70% and <100% or
  • Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
  • The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
  • The lesion length must not exceed 40 mm
  • The target vessel must have TIMI flow 3 at baseline (visually assessed, may be assessed after pre-dilatation)
  • Evidence of calcification at the lesion site by, a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section
  • Ability to pass a 0.014" guide wire across the lesion

Who cannot join

  • 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
Show all 34Show fewer
  • 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
  • Active peptic ulcer or upper gastrointestinal (GI) b≥leeding within 6 months
  • Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
  • Coagulopathy, including but not limited to platelet count <100,000 or International Normalized ratio (INR) >1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
  • Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders
  • Uncontrolled diabetes defined as a HbA1c ≥10%
  • Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
  • Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia)
  • Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
  • Subjects with a life expectancy of less than 1 year
  • Non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days prior to the index procedure
  • Planned non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days after the index procedure
  • Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
  • Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
  • Unprotected left main diameter stenosis >30%
  • Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º
  • Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
  • Evidence of aneurysm in target vessel within 10 mm of the target lesion
  • Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion
  • Target lesion is a bifurcation with ostial diameter stenosis ≥30%
  • Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches
  • Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
  • Previous stent within the target vessel implanted within the last year
  • Previous stent within 10 mm of the target lesion regardless of the timing of its implantation
  • Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Japan8 sites

  • Shonan-Kamakura General Hospital

    Kamakura, Kanagawa, 247-8533

  • Johas Kanto Rosai Hospital

    Kawasaki, Kanagawa, 211-8510

  • Sakurakai Takahashi Hospital

    Kobe, Hyōgo, 654-0026

  • Tenjinkai Shin-Koga Hospital

    Kurume, Fukuoka, 830-8577

  • Kyoto-Katsura Hospital

    Kyoto, Kyoto, 615-8256

  • Miyazaki Medical Association Hospital

    Miyazaki, Miyazaki, 880-2102

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido, 065-0033

  • Higashi-Takarazuka Satoh Hospital

    Takarazuka, Hyōgo, 665-0873

Other trials in Japan

About this study

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

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.

Read the 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.

Being tested
Lithotripsy
Keywords
Intravascular Lithotripsy, Percutaneous Coronary Intervention
Medical subject headings
Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LithotripsyDevice

    Deliver Lithotripsy to the target vessel prior to placing a coronary stent

Study groups in NCT04151628
Study groupRoleWhat they receive
Coronary Lithotripsy SystemExperimentalAll subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System
Receives: Device: Lithotripsy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Within 30 days of index procedure

  2. Percentage of Subjects With Procedural Success

    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

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

Secondary outcomes (64)

  1. Number of Participants With Device Crossing Success

    A secondary endpoint was Device Crossing Success defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: At end of procedure, with a mean total procedure time of 62.5 minutes

  2. Number of Participants With Angiographic Success (Residual Stenosis <50%)

    A secondary endpoint was Angiographic Success defined as stent delivery with <50%residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: At end of procedure, with a mean total procedure time of 62.5 minutes

  3. Number of Participants With Procedural Success (Residual Stenosis <=30%)

    secondary endpoint was Procedural Success defined as stent delivery with aresidual stenosis <=30% (core laboratory assessed) and without in-hospital MACE. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

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

  4. Number of Participants With Angiographic Success (Residual Stenosis <=30%)

    A secondary endpoint was Angiographic Success defined as stent delivery with<=30% residual stenosis and without serious angiographic complications. These secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: At end of procedure, with a mean total procedure time of 62.5 minutes

  5. Number of Participants With Serious Angiographic Complications

    A secondary endpoint was Serious Angiographic Complications defined as severedissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: At end of procedure, with a mean total procedure time of 62.5 minutes

  6. MACE Rate at 6 Months

    The MACE rate at 6 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)- is presented as Kaplan-Meier (K-M) estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 6 months of index procedure

  7. MACE Rate at 12 Months

    The MACE rate at 12 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)- is presented as Kaplan-Meier (K-M) estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 12 months of index procedure

  8. MACE Rate at 24 Months

    The MACE rate at 24 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)- is presented as Kaplan-Meier (K-M) estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 24 months of index procedure

  9. Target Lesion Failure (TLF) at 30 Days

    Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR), and is presented as proportions at 30 days. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: Within 30 days of index procedure

  10. Target Lesion Failure (TLF) at 6 Months

    Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR). TLF is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: Within 6 months of index procedure

  11. Target Lesion Failure (TLF) at 12 Months

    Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR). TLF is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: Within 12 months of index procedure

  12. Target Lesion Failure (TLF) at 24 Months

    Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR). TLF is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: Within 24 months of index procedure

  13. All-Cause Death at 30 Days

    The 30-day rates of all-cause death are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: Within 30 days from index procedure

  14. All-Cause Death at 6 Months

    All-cause death at 6 months is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 6 months of index procedure

  15. All-Cause Death at 12 Months

    All-cause death at 12 month is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 12 months of procedure

  16. All-Cause Death at 24 Months

    All-cause death at 24 month is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 24 months of procedure

  17. Myocardial Infarction (MI) at 30 Days

    The 30-day MI rates are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 30 days of index procedure

  18. Myocardial Infarction (MI) at 6 Months

    MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: Within 6 months of index procedure

  19. Myocardial Infarction (MI) at 12 Months

    MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: Within 12 months of index procedure

  20. Myocardial Infarction (MI) at 24 Months

    MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: Within 24 months of index procedure

  21. Myocardial Infarction Attributable to Target Vessel (TV-MI) at 30 Days

    The Myocardial Infarction attributable to the target vessel (TV-MI) rates at 30 days are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 30 days of index procedure

  22. Myocardial Infarction Attributable to Target Vessel (TV-MI) at 6 Months

    The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: Within 6 month of index procedure

  23. Myocardial Infarction Attributable to Target Vessel (TV-MI) at 12 Months

    The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: Within 12 months of index procedure

  24. Myocardial Infarction Attributable to Target Vessel (TV-MI) at 24 Months

    The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: Within 24 months of index procedure

  25. Stent Thrombosis at 30 Days

    The Stent Thrombosis rate at 30 days is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: Within 30 days of index procedure

  26. Stent Thrombosis at 6 Months

    Stent thrombosis is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 6 months of index procedure

  27. Stent Thrombosis at 12 Months

    Stent thrombosis is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 12 months of index procedure

  28. Stent Thrombosis at 24 Months

    Stent thrombosis is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 24 months of index procedure

  29. All Revascularizations at 30 Days

    The 30-day revascularization rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 30 days of index procedure

  30. All Revascularizations at 6 Months

    All revascularizations are presented as Kaplan-Meier estimated event rates at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 6 months of index procedure

  31. All Revascularizations at 12 Months

    All revascularizations are presented as Kaplan-Meier estimated event rates at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 12 months of index procedure

  32. All Revascularizations at 24 Months

    All revascularizations are presented as Kaplan-Meier estimated event rates at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 24 months of index procedure

  33. Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 30 Days

    The ischemia-driven Target Vessel Revascularization at 30 days is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 30 days of index procedure

  34. Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 6 Months

    The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 6 months of index procedure

  35. Ischemia-driven Target Vessel Revascularization (ID-TVR) at 12 Months

    The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 12 months of index procedure

  36. Ischemia-driven Target Vessel Revascularization (ID-TVR) at 24 Months

    The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 24 months of index procedure

  37. Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 30 Days

    The ischemia-driven Target Lesion Revascularization (ID-TLR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 30 days of index procedure

  38. Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 6 Months

    The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 6 months of index procedure

  39. Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 12 Months

    The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 12 months of index procedure

  40. Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 24 Months

    The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 24 months of index procedure

  41. Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 30 Days

    The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 30 days of index procedure

  42. Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 6 Months

    The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 6 months of index procedure

  43. Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 12 Months

    The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 12 months of index procedure

  44. Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 24 Months

    The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 24 months of index procedure

  45. Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 30 Days

    The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 30 days of index procedure

  46. Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 6 Months

    The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 6 months of index procedure

  47. Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 12 Months

    The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 12 months of index procedure

  48. Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 24 Months

    The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 24 months of index procedure

  49. Procedural MI at 30 Days

    The procedural MI 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 30 days of index procedure

  50. Procedural MI at 6 Months

    The procedural MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 6 months of index procedure

  51. Procedural MI at 12 Months

    The procedural MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 12 months of index procedure

  52. Procedural MI at 24 Months

    The procedural MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 24 months of index procedure

  53. Non-Procedural MI at 30 Days

    The non-procedural MI 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 30 days of index procedure

  54. Non-Procedural MI at 6 Months

    The non-procedural MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 6 months of index procedure

  55. Non-Procedural MI at 12 Months

    The non-procedural MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 12 months of index procedure

  56. Non-Procedural MI at 24 Months

    The non-procedural MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 24 months of index procedure

  57. Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 30 Days

    The 30-day rate of MI using the Fourth Universal Definition of MI is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 30 days of index procedure

  58. Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 6 Months

    MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 6 months of index procedure

  59. Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 12 Months

    MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 12 months of index procedure

  60. Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 24 Months

    MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 24 months of index procedure

  61. Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 30 Days

    The 30-day rate of MI using the SCAI Definition of MI is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 30 days of index procedure

  62. Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 6 Months

    MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 6 months of index procedure

  63. Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 12 Months

    MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 12 months of index procedure

  64. Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 24 Months

    MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

    Measured: within 24 months of index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start6 Nov 2019
  3. Primary completion8 May 2020
  4. Study completion25 Mar 2022

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The Coronary IVL System is a proprietary balloon catheter system designed to enhance stent outcomes by enabling delivering of the calcium disrupting capability of lithotripsy prior to balloon dilatation at low pressures. The Coronary IVL System consists of an IVL Balloon Catheter with 2 integrated emitters, a Lithotripsy Generator, and a Connector Cable.
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04151628
Sponsor's protocol ID
CP 62611
Status last verified
Apr 2022
First submitted
1 Nov 2019
Last updated
22 May 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Saito S, Yamazaki S, Takahashi A, Namiki A, Kawasaki T, Otsuji S, Nakamura S, Shibata Y; Disrupt CAD IV Investigators. Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent Placement - Primary Outcomes From the Japanese Disrupt CAD IV Study. Circ J. 2021 May 25;85(6):826-833. doi: 10.1253/circj.CJ-20-1174. Epub 2021 Feb 5.

    PubMed 33551398

  • Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.

    PubMed 33939604

Questions about this trial

What is this clinical trial studying?

A study testing Lithotripsy in people with Coronary Artery Disease and Myocardial Infarction, run by Shockwave Medical, Inc. at 8 sites in Japan.

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 23 inclusion and 34 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: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 25 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure (time frame: Within 30 days of index procedure). The study lists 2 primary outcomes in all. 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 NCT04151628, which also lists 2 linked publications.

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 22 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in