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Coronary StenosisNCT02758379

Shockwave Coronary Lithoplasty Study

A study testing Shockwave Coronary Lithoplasty System in people with Coronary Stenosis, run by Shockwave Medical, Inc. at 1 site in Australia.

Completed

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

Official record
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Trial summary

The objective of this clinical trial is to study the early safety and feasibility of the Shockwave Coronary Lithoplasty System. To demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, de novo coronary lesions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Stenosis
What is being tested?
Shockwave Coronary Lithoplasty System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteAustralia
Study dates
Jul 2014to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

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

  • At least 18 years of age and able to give informed consent.
  • Patients in Sinus Rhythm.
  • Patients with significant (> 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI.
  • Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel or prasugrel). For 1 year and single therapy for life.
  • Patient is able and willing to comply with all assessments in the study.
  • Stenosis of LAD, RCA or LCX artery ≥50% in a reference vessel of 2.5mm-3.5 mm diameter and ≤ 22 mm length, as assessed by two orthogonal angiographic views.
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  • Calcification with parallel calcium at least 50% the length of the lesion.
  • At the time of the procedure the subject is in Sinus Rhythm.
  • Single lesions per vessel.
  • Ability to pass a 0.014" guide wire across the lesion.

Who cannot join

  • Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
  • Additional planned coronary interventions for a non-target lesion within 180 days of the study procedure.
  • Left ventricular ejection fraction < 40%
  • Patients refusing or not candidates for emergency coronary artery bypass grafting (CABG) surgery
  • Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
  • Patients who are not candidates for dual anti-platelet therapy for 30 days and chronic single anti-platelet therapy
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  • Severe renal failure with creatinine >2.5 mg/dL
  • Untreated pre-procedural hemoglobin <10 g/dL
  • 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)
  • Patients in cardiogenic shock
  • Acute myocardial infarction (MI) within the past one (1) month, and/or elevated CPK (and abnormal Troponin-I) at the time of enrollment
  • Patients with a life expectancy of less than 1 year
  • Target main branch vessel < 2.5 mm in diameter
  • Target main branch lesion > 22 mm in length
  • Chronic Total Occlusion (CTO).
  • Previous stent procedure within 10 mm of target lesion
  • Prior PCI procedure within the last 6 months.
  • Target lesion demonstrating severe dissection prior to planned use of the Shockwave device
  • Unprotected Left Main diameter stenosis ≥ 50%
  • Visible thrombus (by angiography) at target lesion site
  • Patient has active systemic infection
  • Patient with an externally-connected intracardiac catheter or pacemaker.
  • Patient with an implantable pacemaker or defibrillator.
  • Patient has connective tissue disease (e.g., Marfan's syndrome)
  • Patient has a hypercoagulable disorder.
  • Patient has allergy to imaging contrast media for which they cannot be pre-medicated.
  • Evidence of aneurysm or acute thrombus in target vessel.
  • Patients with prior sternotomy as a result of thoracic surgery

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • St. Vincent's Hospital Melbourne

    Melbourne, Victoria

Other trials in Australia

About this study

Official title: Early Safety and Feasibility Study of the Shockwave Coronary Lithoplasty™ System in Coronary Arteries

The objective of this clinical trial is to study the early safety and feasibility of the Shockwave Coronary Lithoplasty System. To demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, de novo coronary lesions.

Read the detailed description

Prospective, non-randomized, single center First In Human (FIH) trial for treatment of stenotic calcified coronary lesions with the Shockwave Lithoplasty System. Patients will be enrolled and consented in the study based on history and in some instances an angiogram obtained prior to the study. The study is designed to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, coronary arteries. Subjects will be prepared for PCI per the institution's standard protocol. Medications will be administered per the treatment protocol. Femoral access will be obtained using a 6F access sheath, and guiding catheter placed at the ostia of the right or left coronary artery. Baseline angiography of the culprit lesion will be performed prior to placement of a 0.014" guide wire. Baseline and either IVUS or OCT will be performed to determine the Maximum Lumen Area (MLA), percent stenosis, and volumetric lesion assessment. Baseline angiography will be performed to determine lesion length, % stenosis and reference vessel diameter. The investigational device will be prepped per the IFU and positioned at the target lesion. The distal end of the balloon catheter will be connected to the patient cable. The balloon catheter will be inflated to 4 atm and the investigator will deliver 10 pulses for 20 seconds. The balloon will then be inflated to reference vessel diameter and then deflated to reestablish flow and complete one treatment cycle. The treatment cycle will then be repeated. Angiography and either IVUS or OCT will be repeated for the treated lesion.. A coronary stent will be deployed at the site of treatment. Angiography and either IVUS or OCT will be performed following stent placement. Patients will be followed through discharge and at 30 and 180 days. A subset of up to five (5) subjects will receive an angiographic assessment at the 180 day follow up visit, per the Sponsor's discretion.

Being tested
Shockwave Coronary Lithoplasty System
Keywords
coronary artery disease, calcified lesions, lithotripsy
Medical subject headings
Coronary Stenosis, Coronary Artery Disease

What participants receive

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

  • Shockwave Coronary Lithoplasty SystemDevice

    Lithotripsy shockwaves are used to fracture calcified lesions in the coronary arteries

Study groups in NCT02758379
Study groupRoleWhat they receive
Shockwave Coronary Lithoplasty SystemExperimentalPatients receive Lithoplasty treatment prior to placement of coronary stent. IVUS or OCT documents patency pre and post Lithoplasty. Patient is followed for patency at discharge, 30 days and 6 months following treatment.
Receives: Device: Shockwave Coronary Lithoplasty System

What is being measured

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

  1. Safety - Acute, as indicated by number of subjects that do not experience death following delivery of shockwave energy

    Measured: Post-procedure (within 24 hours following procedure)

  2. Safety - Acute, as indicated by number of subjects that do not experience tamponade following delivery of shockwave energy

    Measured: Post-procedure (within 24 hours following procedure)

  3. Safety - Acute, as indicated by number of subjects that do not experience dissection, occlusion or perforation of the coronary artery that requires additional intervention to treat besides stenting following delivery of shockwave energy

    Measured: Post-procedure (within 24 hours following procedure)

  4. Safety - Acute, as indicated by number of subjects that do not experience aneurysm following delivery of shockwave energy

    Measured: Post-procedure (within 24 hours following procedure)

  5. Safety - Acute, as indicated by number of subjects that do not experience MI (CPK > 5 x uln) following delivery of shockwave energy

    Measured: Post-procedure (within 24 hours following procedure)

  6. Safety - Acute, as indicated by number of subjects that do not experience cardiogenic shock following delivery of shockwave energy

    Measured: Post-procedure (within 24 hours following procedure)

  7. Safety - Acute, as indicated by number of subjects that do not experience distal embolization compromising blood flow, and requiring intervention following delivery of shockwave energy

    Measured: Post-procedure (within 24 hours following procedure)

  8. Safety - Acute, as indicated by number of subjects that do not experience blood transfusion due to excessive blood loss following delivery of shockwave energy

    Measured: Post-procedure (within 24 hours following procedure)

  9. Safety - Acute, as indicated by number of subjects that do not experience stroke following delivery of shockwave energy

    Measured: Post-procedure (within 24 hours following procedure)

  10. Safety - 30 days (Number of subjects without any procedure and/or device related adverse events)

    Measured: 30 days post procedure

  11. Safety - 30 days (Number of subjects without target lesion revascularization (TLR)

    Measured: 30 days post procedure

  12. Safety - 30 days (Number of subjects without groin complications)

    Measured: 30 days post procedure

  13. Safety - 180 days (Number of subjects without any procedure and/or device related adverse events)

    Measured: 180 days post procedure

  14. Safety - 180 days (Number of subjects without any target lesion revascularization (TLR))

    Measured: 180 days post procedure

  15. Performance - Acute technical success of the device

    • Successful delivery of the device and administration of lithotripsy-enhanced low pressure balloon dilation to the target lesion
    • Residual stenosis of ≤50% of the reference vessel size of the target lesion assessed by angiography and either IVUS or OCT.
    • Successful access of the treatment site with a coronary stent

    Measured: Post-procedure (within 24 hours following procedure)

  16. Safety - Acute, as indicated by number of subjects that do not experience ventricular arrhythmic event requiring intervention to re-establish normal rhythm following delivery of shockwave energy

    Measured: Post-procedure (within 24 hours following procedure)

Timeline

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

  1. First posted2 May 2016 (estimated)
  2. Study startJul 2014
  3. Primary completionJan 2016
  4. Study completionMar 2016

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
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02758379
Sponsor's protocol ID
TD 0200
Status last verified
Jul 2017
First submitted
16 Jan 2015
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Shockwave Coronary Lithoplasty System in people with Coronary Stenosis, run by Shockwave Medical, Inc. at 1 site in Australia.

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 10 inclusion and 28 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety - Acute, as indicated by number of subjects that do not experience death following delivery of shockwave energy (time frame: Post-procedure (within 24 hours following procedure)). The study lists 16 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 NCT02758379.

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 21 Jul 2017.

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