Disrupt CAD IV With the Shockwave Coronary IVL System

NCT04151628 | Completed Results DMC FDA Device

• 1 other identifier: CP 62611
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 8

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.

Conditions

Coronary Artery Disease; Myocardial Infarction

Keywords

Intravascular Lithotripsy; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  Within 30 days of index procedure

• 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

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

Secondary Outcomes (64)

• 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

• 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

Study Arms (1)

Coronary Lithotripsy System

EXPERIMENTAL

All subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System

Device: Lithotripsy

Interventions

Lithotripsy DEVICE

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

Coronary Lithotripsy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \>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
• 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:

You may not qualify if:

• 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
• 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%

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (8)

Tenjinkai Shin-Koga Hospital

Kurume, Fukuoka, 830-8577, Japan

Location

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, 065-0033, Japan

Location

Sakurakai Takahashi Hospital

Kobe, Hyōgo, 654-0026, Japan

Location

Higashi-Takarazuka Satoh Hospital

Takarazuka, Hyōgo, 665-0873, Japan

Location

Shonan-Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan

Location

Johas Kanto Rosai Hospital

Kawasaki, Kanagawa, 211-8510, Japan

Location

Kyoto-Katsura Hospital

Kyoto, Kyoto, 615-8256, Japan

Location

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, 880-2102, Japan

Location

Related Publications (2)

• 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.

  PMID: 33551398 RESULT

• 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.

  PMID: 33939604 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Randee Randoll, Director Clinical Affairs
• Organization: Shockwave Medical Inc

rrandoll@shockwavemedical.com

1-408-577-7856

Study Officials

• Gregg W Stone, MD

  Columbia University

  STUDY CHAIR

• Shigeru Saito, MD

  Shonan Kamakura General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 5, 2019
• Study Start: November 6, 2019
• Primary Completion: May 8, 2020
• Study Completion: March 25, 2022
• Last Updated: May 22, 2023
• Results First Posted: June 25, 2021

Record last verified: 2022-04

Locations

JP (8)