Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Sex
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
NA
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
NA
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
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
6
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01577888