Peripheral Arterial DiseaseBTKNCT02911623
Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis
A study testing Shockwave Lithoplasty® System in people with Peripheral Arterial Disease, run by Shockwave Medical, Inc. at 4 sites in 3 countries.
Trial summary
To observe early safety and performance of the Shockwave Medical Lithoplasty® System (specifically, Lithoplasty® Catheters: 2.5 x 60mm, 2.75 x 60mm, 3.0 x 60mm, 3.25 x 60mm, and 3.5 x 60mm) in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized pulsatile mechanical energy for… 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
- 20 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jun 2016to Jul 2017
- 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
- 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 1 - 5.
- Angiographic Inclusion Criteria:
- Single or multiple target lesion(s) is/are located in a de novo artery distal to the trifurcation vessels and extends to and ends above the ankle
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- Target vessel reference diameter is between 2.5mm and 3.5mm by visual estimate
- Target lesion with diameter stenosis ≥50% by investigator via visual estimate
- If inflow disease >50% proximal to the trifurcation vessels is present, and it can be treated with POBA, stent or Lithoplasty and without complications.
- Target lesion is ≤150mm in length
- Subject has at least one patent tibial vessel (>50%) with run-off to the foot.
- No evidence of aneurysm or acute thrombus in target vessel.
- Any presence of calcification within the target lesion as assessed by imaging (radiograph, CT or angiography).
Who cannot join
- Rutherford Clinical Category 6.
- Target lesion is within only lower extremity vessel with < 50% stenosis.
- Gangrene of the lower extremity.
- Planned major amputation of the target leg.
- Previously implanted stent in the treatment lesion
- Target lesion length exceeds 150mm.
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- Patient has chronic total occlusion of target lesion.
- Patient has significant stenosis (>50% stenosis) or occlusion of inflow tract (e.g., iliac or common femoral) not successfully treated with POBA, stent or Lithoplasty and without complications.
- Patient in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
- Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
- Patient has known allergy to urethane, nylon, or silicone.
- Patient is pregnant or nursing.
- Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Austria2 sites
Medizinische Universitaet Graz
Graz, 8036
Hanusch Krankenhaus
Vienna
Germany1 site
Department of Angiology - Universitats Herzzentrum Freiburg
Bad Krozingen, Baden-Wurttemberg, 79189
About this study
To observe early safety and performance of the Shockwave Medical Lithoplasty® System (specifically, Lithoplasty® Catheters: 2.5 x 60mm, 2.75 x 60mm, 3.0 x 60mm, 3.25 x 60mm, and 3.5 x 60mm) in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized pulsatile mechanical energy for balloon dilation of calcified, stenotic, infrapopliteal arteries.
Read the detailed description
Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the early safety and performance of the Shockwave Lithoplasty® System in subjects with moderate to heavily calcified peripheral arteries with 2.5mm to 3.5mm reference vessel diameter at the target site. The Shockwave Lithoplasty® System is indicated for lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to twenty subjects will be enrolled and treated with Lithoplasty® System.
- 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
The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.
| Study group | Role | What they receive |
|---|---|---|
| Lithoplasty Treatment | Experimental | Patients in this group will receive treatment with the Shockwave Lithoplasty® System which uses lithotripsy-enhanced, low-pressure balloon dilation of calcified stenotic peripheral arteries. 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)
Death Myocardial infarction Need for emergency surgical revascularization of the target limb. Amputation of target limb.
Measured: Procedure through 30 days post procedure
Efficacy
Acute reduction in percent (%) diameter stenosis of target lesion
Measured: Peri-Procedural
Secondary outcomes (1)
Procedural Success
The ability of the Shockwave Lithoplasty® System to achieve a post-shockwave residual diameter stenosis of ≤50%
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 posted22 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shockwave Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Brodmann, MD, Principal investigator, Universitätsklinikum LKH Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911623
- Sponsor's protocol ID
- TD 0258
- Acronym
- BTK
- Status last verified
- Oct 2017
- First submitted
- 16 Sep 2016
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Brodmann M, Holden A, Zeller T. Safety and Feasibility of Intravascular Lithotripsy for Treatment of Below-the-Knee Arterial Stenoses. J Endovasc Ther. 2018 Aug;25(4):499-503. doi: 10.1177/1526602818783989. Epub 2018 Jun 18.
PubMed 29911480
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis
- ClinicalTrials.gov ID
- NCT02911623
- Acronym / sponsor ID
- BTK / TD 0258
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 22 Sep 2016 (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 observe early safety and performance of the Shockwave Medical Lithoplasty® System (specifically, Lithoplasty® Catheters: 2.5 x 60mm, 2.75 x 60mm, 3.0 x 60mm, 3.25 x 60mm, and 3.5 x 60mm) in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized pulsatile mechanical energy for balloon dilation of calcified, stenotic, infrapopliteal arteries.
Detailed description
Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the early safety and performance of the Shockwave Lithoplasty® System in subjects with moderate to heavily calcified peripheral arteries with 2.5mm to 3.5mm reference vessel diameter at the target site. The Shockwave Lithoplasty® System is indicated for lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to twenty subjects will be enrolled and treated with Lithoplasty® System.
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® SystemPatients in this group will receive treatment with the Shockwave Lithoplasty® System which uses 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 (13 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 1 - 5.
- Single or multiple target lesion(s) is/are located in a de novo artery distal to the trifurcation vessels and extends to and ends above the ankle
Key exclusion criteria (13 listed)
- Rutherford Clinical Category 6.
- Target lesion is within only lower extremity vessel with < 50% stenosis.
- Gangrene of the lower extremity.
- Planned major amputation of the target leg.
- Previously implanted stent in the treatment lesion
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® SystemThe Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator. | Device | Lithoplasty Treatment |
Primary outcome
Composite of new-onset Major Adverse Events (MAE)
Time frame: Procedure through 30 days post procedure
Death Myocardial infarction Need for emergency surgical revascularization of the target limb. Amputation of target limb.
Efficacy
Time frame: Peri-Procedural
Acute reduction in percent (%) diameter stenosis of target lesion
1 secondary outcome
Procedural Success
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 9 Oct 2017.
- Derived from this study: PubMed 29911480Brodmann M, Holden A, Zeller T. Safety and Feasibility of Intravascular Lithotripsy for Treatment of Below-the-Knee Arterial Stenoses. J Endovasc Ther. 2018 Aug;25(4):499-503. doi: 10.1177/1526602818783989. Epub 2018 Jun 18.
- Individual participant dataSharing planned: Undecided
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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.
Marianne Brodmann, MD principal investigator
Universitätsklinikum LKH Graz
4 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 4 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 13 inclusion and 13 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 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Composite of new-onset Major Adverse Events (MAE) (time frame: Procedure through 30 days post procedure). 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?
On the ClinicalTrials.gov record for NCT02911623, which also lists 1 linked publication.
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 9 Oct 2017.