Vascular DiseaseNCT01577888
Safety and Feasibility Study of the Shockwave Lithoplasty System
A study testing Shockwave System Treatment in people with Vascular Disease, run by Shockwave Medical, Inc. at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Disease
- What is being tested?
- Shockwave System Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNew Zealand
- Study dates
- Aug 2012to Aug 2014
- 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
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Shockwave Medical, Inc. intends to conduct a prospective, single-arm, single-center, First in Human study designed to evaluate the early safety and feasibility of the Shockwave Lithoplasty System in subjects with heavily calcified infrainguinal arteries with 3.75mm to 6mm reference vessel diameter at target site. The Shockwave Lithoplasty System is indicated to generate sonic shockwave energy within the target treatment site and disrupt calcium within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low balloon pressure. Up to 10 subjects will be enrolled to undergo lihtoplasty.
- Conditions
- Vascular Disease
- Being tested
- Shockwave System Treatment
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave System TreatmentDevice
Shockwave System Treatment during vascular disease intervention.
| Study group | Role | What they receive |
|---|---|---|
| Lithotripsy Treatment | Experimental | Shockwave System Treatment -Lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries. Receives: Device: Shockwave System Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 day
Secondary outcomes (1)
Angiographic Success as measured by residual stenosis <30% reference vessel.
Measured: Peri-Procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shockwave Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, MD, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577888
- Sponsor's protocol ID
- TD-0047
- Status last verified
- Aug 2014
- First submitted
- 11 Apr 2012
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of the Shockwave Lithoplasty System
- ClinicalTrials.gov ID
- NCT01577888
- Acronym / sponsor ID
- TD-0047
- Conditions
- Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Shockwave Medical, Inc. intends to conduct a prospective, single-arm, single-center, First in Human study designed to evaluate the early safety and feasibility of the Shockwave Lithoplasty System in subjects with heavily calcified infrainguinal arteries with 3.75mm to 6mm reference vessel diameter at target site. The Shockwave Lithoplasty System is indicated to generate sonic shockwave energy within the target treatment site and disrupt calcium within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low balloon pressure. Up to 10 subjects will be enrolled to undergo lihtoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lithotripsy Treatment | Experimental | Device: Shockwave System TreatmentShockwave System Treatment -Lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave System TreatmentShockwave System Treatment during vascular disease intervention. | Device | Lithotripsy Treatment |
Primary outcome
Safety determined by 30day New-Onset Serious Adverse Events
Time frame: 30 day
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.
1 secondary outcome
Angiographic Success as measured by residual stenosis <30% reference vessel.
Time frame: Peri-Procedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Holden, MD principal investigator
Auckland City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave System Treatment in people with Vascular Disease, run by Shockwave Medical, Inc. at 1 site in New Zealand.
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 7 inclusion and 21 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 8 Aug 2014. 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 New Zealand. 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 determined by 30day New-Onset Serious Adverse Events (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2014.