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Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03328949
Recruitment Status : Completed
First Posted : November 1, 2017
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Shockwave Medical, Inc.

Tracking Information
First Submitted Date  ICMJE October 27, 2017
First Posted Date  ICMJE November 1, 2017
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE May 18, 2018
Actual Primary Completion Date March 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
In-hospital major adverse cardiac events (MACE) [ Time Frame: 1 day post-procedure ]
The primary safety endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following:
  • Cardiac death
  • MI - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave
  • TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03328949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • Residual stenosis (<50%) after stenting [ Time Frame: Procedural ]
    Performance will be assessed by the ability of the Lithotripsy System to produce acceptable residual stenosis (<50%) after stenting with no evidence of in-hospital MACE. Each patient that achieves both of these requirements will be considered a "clinical success", and the rate of clinical success among subjects will be evaluated.
  • Angiographic success [ Time Frame: Procedural ]
    Angiographic success defined as success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
  • Cardiac Death [ Time Frame: 30 days ]
    Cardiac death at 30 days.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • Residual stenosis (<50%) after stenting [ Time Frame: Procedural ]
    Performance will be assessed by the ability of the Lithoplasty System to produce acceptable residual stenosis (<50%) after stenting with no evidence of in-hospital MACE. Each patient that achieves both of these requirements will be considered a "clinical success", and the rate of clinical success among subjects will be evaluated.
  • Angiographic success [ Time Frame: Procedural ]
    Angiographic success defined as success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
  • Cardiac Death [ Time Frame: 30 days ]
    Cardiac death at 30 days.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)
Official Title  ICMJE Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries
Brief Summary The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.
Detailed Description

The study will be conducted at 15 sites in Europe and up to 120 participants will be followed for 30 days post procedure.

Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1) cardiac related death, 2) heart attack, and 3) intervention to treat the coronary artery that was previously treated at the procedure visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Intravascular Coronary Lithotripsy System
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Device: IVL Coronary Lithotripsy System
The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy).
Study Arms  ICMJE Experimental: IVL Coronary Lithotripsy System
All enrolled patients will receive treatment from the IVL coronary lithotripsy system prior to coronary stent placement.
Intervention: Device: IVL Coronary Lithotripsy System
Publications * Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 25, 2019
Actual Primary Completion Date March 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient is ≥ 18 years of age
  2. Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure OR if troponin is elevated, concomitant CK must be normal
  3. The target vessel must have a TIMI flow 3 at baseline
  4. Patients with significant (≥ 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
  5. Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor) for 1 year and single antiplatelet therapy for life
  6. Single lesion stenosis of protected LMCA, or LAD, RCA or LCX artery ≥50% in a reference vessel of 2.5 mm - 4.0 mm diameter and ≤ 32 mm length
  7. Presence of calcification within the lesion on both sides of the vessel as assessed by angiography
  8. Planned treatment of single lesion in one vessel
  9. Ability to pass a 0.014" guide wire across the lesion
  10. Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
  11. Patient is able and willing to comply with all assessments in the study

Exclusion Criteria:

  1. Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices
  2. Prior PCI procedure within the last 30 days of the index procedure
  3. Patient has planned cardiovascular interventions within 30 days post index procedure
  4. Second lesion with ≥50% stenosis in the same target vessel
  5. Left ventricular ejection fraction < 40%
  6. Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
  7. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
  8. Severe renal failure with serum creatinine >2.5 mg/dL, unless on chronic dialysis
  9. Untreated pre-procedural hemoglobin <10 g/dL
  10. Coagulopathy manifested by platelet count <100,000 or International Normalized ratio (INR) >1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment)
  11. Patients in cardiogenic shock
  12. Acute myocardial infarction (MI) within the past one (1) month, and/or signs of active myocardial ischemia at the time of enrollment including elevated Troponin-I or T (with concomitant elevation of CK), ischemic ECG changes or chest pain
  13. History of a stroke or transient ischemic attack (TIA) within 3 months
  14. NYHA class III or IV heart failure
  15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
  16. Patients with a life expectancy of less than 1 year
  17. Target vessel < 2.4 mm in diameter
  18. Target lesion > 32 mm in length
  19. Chronic Total Occlusion (CTO)
  20. Previous stent procedure within 5 mm of target lesion
  21. Angiographic evidence of a target lesion severe dissection prior to Coronary Lithoplasty treatment
  22. Unprotected Left Main diameter stenosis ≥ 50%
  23. Visible thrombus (by angiography) at target lesion site
  24. Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass
  25. Patient has active systemic infection
  26. Patient has connective tissue disease (e.g., Marfan's syndrome)
  27. Patient has a hypercoagulable disorder
  28. Uncontrolled insulin dependent diabetes
  29. Patient has allergy to imaging contrast media for which they cannot be pre-medicated
  30. Evidence of aneurysm in target vessel
  31. Patient is pregnant or nursing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Denmark,   France,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03328949
Other Study ID Numbers  ICMJE CP61774
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shockwave Medical, Inc.
Study Sponsor  ICMJE Shockwave Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean Fajadet, MD Clinic Pasteur
Principal Investigator: Carlo DiMario, MD University of Florence
PRS Account Shockwave Medical, Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP