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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01577888




Registration number
NCT01577888
Ethics application status
Date submitted
11/04/2012
Date registered
16/04/2012
Date last updated
8/08/2014

Titles & IDs
Public title
Safety and Feasibility Study of the Shockwave Lithoplasty System
Scientific title
Safety and Feasibility Study of the Shockwave Lithoplasty System
Secondary ID [1] 0 0
TD-0047
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Shockwave System Treatment

Experimental: Lithotripsy Treatment - Shockwave System Treatment -Lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries.


Treatment: Devices: Shockwave System Treatment
Shockwave System Treatment during vascular disease intervention.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety determined by 30day New-Onset Serious Adverse Events - New Onset Serious Adverse Events (SAE) include death, device-related surgery or repeat hospitalization, occlusion, or major unplanned amputation through 30 days following the procedure.
Timepoint [1] 0 0
30 day
Secondary outcome [1] 0 0
Angiographic Success as measured by residual stenosis <30% reference vessel.
Timepoint [1] 0 0
Peri-Procedural

Eligibility
Key inclusion criteria
- Age >18

- Patient or patient's legal representative have been informed of the nature of the
study, agrees to participate and has signed the approved consent form.

- Female subjects of childbearing potential have a negative pregnancy test less than 7
days before the procedure.

- Patient is able and willing to comply with all assessments in the study.

- Peripheral arterial disease of Rutherford Category 2, 3, 4, and 5.

- Ability to tolerate an antiplatelet agent (i.e. aspirin, clopidigrel or prasagrel).

- Meets Angiographic Inclusion Criteria
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with peripheral arterial disease of Rutherford Category 6.

- Severe or infected gangrene of the lower extremity.

- Planned major amputation.

- Previously implanted stent at the treatment site.

- 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 premedicated.

- Patient is in acute renal failure or chronic renal insufficiency or failure as
measured by a serum creatinine of >19.5 µmol/L.

- Patient has active systemic infection.

- Patient has less than a one year life expectancy.

- Patient is pregnant or nursing.

- Patient is participating in another research study involving an investigational agent
that has not reached the primary endpoint.

- Patient has other medical, social or psychological problems that, in the opinion of
the investigator, preclude them from receiving this treatment, and the procedures and
evaluations pre- and post-treatment.

- Chronic total occlusion of target vessel.

- Chronic total occlusion of inflow vessel.

- Highly tortuous arteries (bends greater than 30 degrees over the arc length of the
balloon)

- Patients requiring concurrent intervention below the most distal target lesion.

- Inflow disease: Stenosis of >50% in vessel proximal to the target lesion which
requires treatment with Drug Eluting Balloon (DEB) or atherectomy.

- Prior procedure in target leg within past 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shockwave Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To study the early safety and performance of the Shockwave Medical System in subjects to
demonstrate that the device can safely and effectively deliver localized energy for the
treatment of vascular disease.
Trial website
https://clinicaltrials.gov/show/NCT01577888
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, MD
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications