Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02758379
Registration number
NCT02758379
Ethics application status
Date submitted
16/01/2015
Date registered
2/05/2016
Date last updated
21/07/2017
Titles & IDs
Public title
Shockwave Coronary Lithoplasty Study
Query!
Scientific title
Early Safety and Feasibility Study of the Shockwave Coronary Lithoplasty™ System in Coronary Arteries
Query!
Secondary ID [1]
0
0
TD 0200
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Coronary Stenosis
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Devices - Shockwave Coronary Lithoplasty System
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.
Treatment: Devices: Shockwave Coronary Lithoplasty System
Lithotripsy shockwaves are used to fracture calcified lesions in the coronary arteries
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Safety - Acute, as indicated by number of subjects that do not experience death following delivery of shockwave energy
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Post-procedure (within 24 hours following procedure)
Query!
Primary outcome [2]
0
0
Safety - Acute, as indicated by number of subjects that do not experience tamponade following delivery of shockwave energy
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Post-procedure (within 24 hours following procedure)
Query!
Primary outcome [3]
0
0
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
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Post-procedure (within 24 hours following procedure)
Query!
Primary outcome [4]
0
0
Safety - Acute, as indicated by number of subjects that do not experience aneurysm following delivery of shockwave energy
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Post-procedure (within 24 hours following procedure)
Query!
Primary outcome [5]
0
0
Safety - Acute, as indicated by number of subjects that do not experience MI (CPK > 5 x uln) following delivery of shockwave energy
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Post-procedure (within 24 hours following procedure)
Query!
Primary outcome [6]
0
0
Safety - Acute, as indicated by number of subjects that do not experience cardiogenic shock following delivery of shockwave energy
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Post-procedure (within 24 hours following procedure)
Query!
Primary outcome [7]
0
0
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
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Post-procedure (within 24 hours following procedure)
Query!
Primary outcome [8]
0
0
Safety - Acute, as indicated by number of subjects that do not experience blood transfusion due to excessive blood loss following delivery of shockwave energy
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Post-procedure (within 24 hours following procedure)
Query!
Primary outcome [9]
0
0
Safety - Acute, as indicated by number of subjects that do not experience stroke following delivery of shockwave energy
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Post-procedure (within 24 hours following procedure)
Query!
Primary outcome [10]
0
0
Safety - 30 days (Number of subjects without any procedure and/or device related adverse events)
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
30 days post procedure
Query!
Primary outcome [11]
0
0
Safety - 30 days (Number of subjects without target lesion revascularization (TLR)
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
30 days post procedure
Query!
Primary outcome [12]
0
0
Safety - 30 days (Number of subjects without groin complications)
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
30 days post procedure
Query!
Primary outcome [13]
0
0
Safety - 180 days (Number of subjects without any procedure and/or device related adverse events)
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
180 days post procedure
Query!
Primary outcome [14]
0
0
Safety - 180 days (Number of subjects without any target lesion revascularization (TLR))
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
180 days post procedure
Query!
Primary outcome [15]
0
0
Performance - Acute technical success of the device
Query!
Assessment method [15]
0
0
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
Query!
Timepoint [15]
0
0
Post-procedure (within 24 hours following procedure)
Query!
Primary outcome [16]
0
0
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
Query!
Assessment method [16]
0
0
Query!
Timepoint [16]
0
0
Post-procedure (within 24 hours following procedure)
Query!
Eligibility
Key inclusion criteria
1. At least 18 years of age and able to give informed consent.
2. Patients in Sinus Rhythm.
3. Patients with significant (> 50% diameter stenosis) native coronary artery disease
including stable or unstable angina and silent ischemia, suitable for PCI.
4. Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel or prasugrel).
For 1 year and single therapy for life.
5. Patient is able and willing to comply with all assessments in the study.
6. 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.
7. Calcification with parallel calcium at least 50% the length of the lesion.
8. At the time of the procedure the subject is in Sinus Rhythm.
9. Single lesions per vessel.
10. Ability to pass a 0.014" guide wire across the lesion.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
2. Additional planned coronary interventions for a non-target lesion within 180 days of
the study procedure.
3. Left ventricular ejection fraction < 40%
4. Patients refusing or not candidates for emergency coronary artery bypass grafting
(CABG) surgery
5. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
6. Patients who are not candidates for dual anti-platelet therapy for 30 days and chronic
single anti-platelet therapy
7. Severe renal failure with creatinine >2.5 mg/dL
8. Untreated pre-procedural hemoglobin <10 g/dL
9. 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)
10. Patients in cardiogenic shock
11. Acute myocardial infarction (MI) within the past one (1) month, and/or elevated CPK
(and abnormal Troponin-I) at the time of enrollment
12. Patients with a life expectancy of less than 1 year
13. Target main branch vessel < 2.5 mm in diameter
14. Target main branch lesion > 22 mm in length
15. Chronic Total Occlusion (CTO).
16. Previous stent procedure within 10 mm of target lesion
17. Prior PCI procedure within the last 6 months.
18. Target lesion demonstrating severe dissection prior to planned use of the Shockwave
device
19. Unprotected Left Main diameter stenosis = 50%
20. Visible thrombus (by angiography) at target lesion site
21. Patient has active systemic infection
22. Patient with an externally-connected intracardiac catheter or pacemaker.
23. Patient with an implantable pacemaker or defibrillator.
24. Patient has connective tissue disease (e.g., Marfan's syndrome)
25. Patient has a hypercoagulable disorder.
26. Patient has allergy to imaging contrast media for which they cannot be pre-medicated.
27. Evidence of aneurysm or acute thrombus in target vessel.
28. Patients with prior sternotomy as a result of thoracic surgery
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/03/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
12
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
St. Vincent's Hospital Melbourne - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
- Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Shockwave Medical, Inc.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Yale Cardiovascular Research Group
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Massachusetts General Hospital
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
Pacific Clinical Research Group
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02758379
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Robert Whitbourn, M.D.
Query!
Address
0
0
St. Vincent Hospital, Melbourne, Australia
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02758379
Download to PDF