Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)

November 7, 2019 updated by: Shockwave Medical, Inc.

Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • Onze-Lieve-Vrouwziekenhuis
  • Denmark
      • Aarhus, Denmark
        • Aarhus Universitetshospital
  • France
      • Massy, France
        • Institut Hospitalier Jacques Cartier
      • Toulouse, France
        • Clinique Pasteur
  • Germany
      • Bad Krozingen, Germany
        • Universitaets-Herzzentrum Freiburg- Bad Krozingen
      • Bonn, Germany
        • Universitaetsklinikum Bonn
      • Gießen, Germany
        • UKGM Universitaetsklinikum Giessen
  • Italy
      • Firenze, Italy
        • AOU Careggi SOD Interventistica
      • Milan, Italy
        • San Raffaelle Hospital
  • Netherlands
      • Rotterdam, Netherlands
        • Thorax Center, Erasmus MC
      • Zwolle, Netherlands
        • Isala Zeikenhuis- Hartecentrum
  • Spain
      • Madrid, Spain
        • Hospital Universitario San Carlos
  • Sweden
      • Uppsala, Sweden
        • Uppsala University Hospital
  • United Kingdom
      • London, United Kingdom
        • King's College Hospital
      • Oxford, United Kingdom
        • Oxford University Hospitals, John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IVL Coronary Lithotripsy System
All enrolled patients will receive treatment from the IVL coronary lithotripsy system prior to coronary stent placement.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
Time Frame: Post-procedure through hospital discharge

The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following:

  • Cardiac death
  • Myocardial Infarction - 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
Post-procedure through hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Success
Time Frame: During procedure through hospital discharge
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.
During procedure through hospital discharge
Number of Participants With Angiographic Success
Time Frame: During procedure
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.
During procedure
Number of Participants Which Experienced Cardiac Death
Time Frame: 30 days post-procedure
Number of patients who experienced a cardiac death at 30 days post-procedure.
30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shockwave Medical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean Fajadet, MD, Clinic Pasteur
  • Principal Investigator: Carlo DiMario, MD, University of Florence

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP61774

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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