- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02758379
Shockwave Coronary Lithoplasty Study
July 19, 2017 updated by: Shockwave Medical, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- 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
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Victoria
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Melbourne, Victoria, Australia
- St. Vincent's Hospital Melbourne
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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
- 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
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 |
Intervention / Treatment |
---|---|
Experimental: Shockwave Coronary Lithoplasty System
Patients 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.
|
Lithotripsy shockwaves are used to fracture calcified lesions in the coronary arteries
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Post-procedure (within 24 hours following procedure)
|
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Safety - Acute, as indicated by number of subjects that do not experience tamponade following delivery of shockwave energy
Time Frame: Post-procedure (within 24 hours following procedure)
|
Post-procedure (within 24 hours following procedure)
|
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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
Time Frame: Post-procedure (within 24 hours following procedure)
|
Post-procedure (within 24 hours following procedure)
|
|
Safety - Acute, as indicated by number of subjects that do not experience aneurysm following delivery of shockwave energy
Time Frame: Post-procedure (within 24 hours following procedure)
|
Post-procedure (within 24 hours following procedure)
|
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Safety - Acute, as indicated by number of subjects that do not experience MI (CPK > 5 x uln) following delivery of shockwave energy
Time Frame: Post-procedure (within 24 hours following procedure)
|
Post-procedure (within 24 hours following procedure)
|
|
Safety - Acute, as indicated by number of subjects that do not experience cardiogenic shock following delivery of shockwave energy
Time Frame: Post-procedure (within 24 hours following procedure)
|
Post-procedure (within 24 hours following procedure)
|
|
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
Time Frame: Post-procedure (within 24 hours following procedure)
|
Post-procedure (within 24 hours following procedure)
|
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Safety - Acute, as indicated by number of subjects that do not experience blood transfusion due to excessive blood loss following delivery of shockwave energy
Time Frame: Post-procedure (within 24 hours following procedure)
|
Post-procedure (within 24 hours following procedure)
|
|
Safety - Acute, as indicated by number of subjects that do not experience stroke following delivery of shockwave energy
Time Frame: Post-procedure (within 24 hours following procedure)
|
Post-procedure (within 24 hours following procedure)
|
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Safety - 30 days (Number of subjects without any procedure and/or device related adverse events)
Time Frame: 30 days post procedure
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30 days post procedure
|
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Safety - 30 days (Number of subjects without target lesion revascularization (TLR)
Time Frame: 30 days post procedure
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30 days post procedure
|
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Safety - 30 days (Number of subjects without groin complications)
Time Frame: 30 days post procedure
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30 days post procedure
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Safety - 180 days (Number of subjects without any procedure and/or device related adverse events)
Time Frame: 180 days post procedure
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180 days post procedure
|
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Safety - 180 days (Number of subjects without any target lesion revascularization (TLR))
Time Frame: 180 days post procedure
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180 days post procedure
|
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Performance - Acute technical success of the device
Time Frame: Post-procedure (within 24 hours following procedure)
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Post-procedure (within 24 hours following procedure)
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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
Time Frame: Post-procedure (within 24 hours following procedure)
|
Post-procedure (within 24 hours following procedure)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Whitbourn, M.D., St. Vincent Hospital, Melbourne, Australia
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
July 1, 2014
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
January 16, 2015
First Submitted That Met QC Criteria
April 27, 2016
First Posted (Estimate)
May 2, 2016
Study Record Updates
Last Update Posted (Actual)
July 21, 2017
Last Update Submitted That Met QC Criteria
July 19, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TD 0200
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.
No
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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