Peripheral Arterial DiseaseDISRUPT-PADNCT02071108
Safety and Performance Study of the Shockwave Lithoplasty System
A study testing Shockwave Lithoplasty System in people with Peripheral Arterial Disease, run by Shockwave Medical, Inc. at 3 sites in 3 countries.
Trial summary
To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, infrainguinal peripheral arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Shockwave Lithoplasty System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject is able and willing to comply with all assessments in the study.
- Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
- Age of subject is >18.
- Rutherford Clinical Category 2, 3, or 4.
- Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg.
- Moderate to severe calcification of target lesion(s) per pre-procedure CT scan. (Calcification must be: 1) ≥180 degrees circumferential at some point in the lesion and 2) extend ≥50 percent length of lesion or absolute length ≥20mm.)
- Estimated life expectancy >1 year.
Who cannot join
- Rutherford Clinical Category 5 and 6.
- Subject has active infection in the target leg.
- Planned major amputation of the target leg (transmetatarsal or higher).
- In-stent restenosis within the target lesion(s).
- Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
- Chronic total occlusion of the target lesion(s).
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- Target lesion(s) within native or synthetic vessel grafts.
- Chronic total occlusion of inflow vessel.
- Lesion in contralateral limb requiring intervention within the next 30 days.
- History of prior endovascular or surgical procedure on the index limb within the past 30 days.
- Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract (upstream disease) not successfully treated with plain old balloon angioplasty or stent and without complications before target lesion(s) treatment.
- Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target lesion(s) at the time of the enrollment / index procedure.
- Subject has a known coagulopathy or has a bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter, or international normalized ratio >1.5.
- Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
- Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
- Subject has known allergy to urethane, nylon, or silicone.
- Myocardial infarction within 60 days prior to enrollment.
- History of stroke within 60 days prior to enrollment.
- History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
- History of thrombolytic therapy within two weeks of enrollment.
- Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L), or on dialysis.
- Subject is pregnant or nursing.
- Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
- Subject 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Department of Angiology - Universitats Herzzentrum Freiburg
Bad Krozingen, Baden-Wurttemberg, 79189
About this study
To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, infrainguinal peripheral arteries.
Read the detailed description
Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the safety and performance of the Shockwave Lithoplasty System in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm reference vessel diameter at the 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 thirty-five (35) subjects will be enrolled and treated with Lithoplasty to yield thirty (30) evaluable subjects complete the study assuming a 15% lost to follow-up rate.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Shockwave Lithoplasty System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave Lithoplasty SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Lithoplasty Treatment | Experimental | Shockwave Lithoplasty System Receives: Device: Shockwave Lithoplasty System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of New-onset Major Adverse Events (MAE)
Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure or noted angiographically, and requiring mechanical or pharmacologic means to improve flow. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.
Measured: 30 days
Procedural Success:
The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty therapy) as assessed by quantitative angiography via core lab evaluation.
Measured: Day of Procedure
Secondary outcomes (13)
Device Success
The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive percutaneous transluminal angioplasty therapy) as assessed via quantitative angiography via core lab evaluation.
Measured: Day of Procedure
Clinical Success:
The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive percutaneous transluminal angioplasty therapy) as assessed by the investigator via visual estimate and freedom from procedural major adverse events.
Measured: Day of Procedure
Technical Success:
The ability of the Shockwave Medical Lithoplasty System to delivery ShockWave treatment to the desired location in the target vessel. Up to two Shockwave Medical Lithoplasty Systems maybe used to complete treatment in the target vessel.
Measured: Day of Procedure
Freedom From Major Adverse Events
Freedom from Major Adverse Events at 30 days.
Measured: 30 days
Freedom From Target Lesion Revascularization (TLR)
Freedom from Target Lesion Revascularization (TLR) at 30 days
Measured: 30 days
Patency
Vessel patency at 30 days by Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of ≥2.5).
Measured: 30 days
Ankle Brachial Index (ABI)
Change in Ankle Brachial Index (ABI) of the target limb at 30 days. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.
Measured: Baseline and 30 days
Rutherford Clinical Category
Change in Rutherford Clinical Category (RCC) at 30 days. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.
Measured: Baseline and 30 days
Freedom From Major Adverse Events
Freedom from Major Adverse Events at 6 months
Measured: 6 months
Freedom From Target Lesion Revascularization (TLR)
Freedom from Target Lesion Revascularization (TLR) at 6 months
Measured: 6 months
Patency
Vessel patency at 6 months at Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of =2.5).
Measured: 6 months
Ankle Brachial Index (ABI)
Change in Ankle Brachial Index (ABI) of the target limb at 6 months. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.
Measured: Baseline and 6 months
Rutherford Clinical Category
Change in Rutherford Clinical Category (RCC) at 6 months. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shockwave Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Zeller, MD, Principal investigator, Bad KrozingenAndrew Holden, MD, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071108
- Sponsor's protocol ID
- TD 0083
- Acronym
- DISRUPT-PAD
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2014
- Last updated
- 24 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Study of the Shockwave Lithoplasty System
- ClinicalTrials.gov ID
- NCT02071108
- Acronym / sponsor ID
- DISRUPT-PAD / TD 0083
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Posted 11 Oct 2016
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 safety and performance of the Shockwave Medical Lithoplasty System in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, infrainguinal peripheral arteries.
Detailed description
Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the safety and performance of the Shockwave Lithoplasty System in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm reference vessel diameter at the 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 thirty-five (35) subjects will be enrolled and treated with Lithoplasty to yield thirty (30) evaluable subjects complete the study assuming a 15% lost to follow-up rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lithoplasty Treatment | Experimental | Device: Shockwave Lithoplasty SystemShockwave Lithoplasty System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is able and willing to comply with all assessments in the study.
- Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
- Age of subject is >18.
- Rutherford Clinical Category 2, 3, or 4.
- Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg.
Key exclusion criteria (24 listed)
- Rutherford Clinical Category 5 and 6.
- Subject has active infection in the target leg.
- Planned major amputation of the target leg (transmetatarsal or higher).
- In-stent restenosis within the target lesion(s).
- Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
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 Lithoplasty System | Device | Lithoplasty Treatment |
Primary outcome
Composite of New-onset Major Adverse Events (MAE)
Time frame: 30 days
Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure or noted angiographically, and requiring mechanical or pharmacologic means to improve flow. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.
Procedural Success:
Time frame: Day of Procedure
The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty therapy) as assessed by quantitative angiography via core lab evaluation.
13 secondary outcomes
Device Success
Time frame: Day of Procedure
Clinical Success:
Time frame: Day of Procedure
Technical Success:
Time frame: Day of Procedure
Freedom From Major Adverse Events
Time frame: 30 days
Freedom From Target Lesion Revascularization (TLR)
Time frame: 30 days
Patency
Time frame: 30 days
Ankle Brachial Index (ABI)
Time frame: Baseline and 30 days
Rutherford Clinical Category
Time frame: Baseline and 30 days
Freedom From Major Adverse Events
Time frame: 6 months
Freedom From Target Lesion Revascularization (TLR)
Time frame: 6 months
Patency
Time frame: 6 months
Ankle Brachial Index (ABI)
Time frame: Baseline and 6 months
Rutherford Clinical Category
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas Zeller, MD principal investigator
Bad Krozingen
Andrew Holden, MD principal investigator
Auckland City Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave Lithoplasty System in people with Peripheral Arterial Disease, run by Shockwave Medical, Inc. at 3 sites in 3 countries.
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 24 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 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany, 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?
Yes. Results are posted in the registry (first posted 11 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite of New-onset Major Adverse Events (MAE) (time frame: 30 days). The study lists 2 primary outcomes in all. 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 24 Mar 2017.