Peripheral Arterial DiseaseNCT05058456
Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System
A study testing Shockwave Medical Mini S Peripheral IVL Catheter in people with Peripheral Arterial Disease, run by Shockwave Medical, Inc. at 4 sites in 2 countries.
Trial summary
Prospective, multi-center, single-arm feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic 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 Medical Mini S Peripheral IVL Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 16 Mar 2022to 5 Dec 2024
- 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
- -General Inclusion Criteria
- Age of subject is ≥ 18 years.
- Subject is able and willing to comply with all assessments in the study.
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
- Estimated life expectancy > 1 year.
- Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s).
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- Angiographic Inclusion Criteria
- One or two target lesion(s) located in a native de novo superficial femoral, popliteal or infrapopliteal artery (above the ankle joint), in one or both limbs.
- Target lesion reference vessel diameter (RVD) between 2.0 mm and 7.0 mm by investigator visual estimate.
- Target lesion stenosis ≥70% (for vessels below the knee defined as P3 to the ankle joint) or ≥90% (for vessels above the knee) by investigator visual estimate.
- Target lesion length is ≤150 mm by investigator visual estimate. Target lesion can be all or part of the 150 mm treated zone.
- Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.
Who cannot join
- General Exclusion Criteria
- Rutherford Clinical Category 0, 1 and 6 (target limb).
- History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure. Note: inflow treatment of non-target lesions is allowed providing successful treatment.
- Subject in whom antiplatelet or anticoagulant 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.
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- Myocardial infarction within 60 days prior to enrollment.
- History of stroke within 60 days prior to enrollment.
- Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy.
- 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.
- Covid-19 diagnosis within 30 days.
- Planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesion(s) during the index procedure.
- Planned major amputation of target limb.
- Acute limb ischemia.
- Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).
- Subject already enrolled into this study.
- Angiographic Exclusion Criteria
- Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries with ≤30% residual stenosis, and no serious angiographic complications (e.g. embolism).
- Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism).
- Target lesion includes in-stent restenosis.
- Evidence of aneurysm or thrombus in target vessel.
- No calcium or mild calcium in the target lesion.
- Target lesion within native or synthetic vessel grafts.
- Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia2 sites
Sir Charles Gairdner Hospital
Nedlands, Perth
Royal Perth Hospital
Perth
New Zealand2 sites
Auckland City Hospital
Auckland
Waikato Hospital
Hamilton
About this study
Official title: Prospective, Multi-center, Single-arm Feasibility Study of the Shockwave Medical Mini S Peripheral Intravascular Lithotripsy (IVL) System
Prospective, multi-center, single-arm feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Shockwave Medical Mini S Peripheral IVL Catheter
- 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 Medical Mini S Peripheral IVL CatheterDevice
The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Not described Receives: Device: Shockwave Medical Mini S Peripheral IVL Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety: Major Adverse Events (MAE)
Major Adverse Events (MAE) at 30 days defined as a composite of:
- Cardiovascular Death
- Clinically Driven Target Lesion Revascularization (CD-TLR)
- Unplanned Target Limb Major Amputation (Above the Ankle)
Measured: 30 days
Primary Performance: Technical Success
Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core lab
Measured: Peri-Procedural
Secondary outcomes (7)
Serious Angiographic Complications
Defined as flow-limiting dissection (≥ Grade D), perforation, distal embolization, or acute vessel closure as assessed by the angiographic core laboratory.
Measured: Peri-Procedural
IVL Technical Success (Post- Dilatation)
Defined as post-dilatation residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion, assessed by angiographic core laboratory (measured immediately following mandatory post-dilatation).
Measured: Peri-Procedural
IVL Device Success
Defined as the ability to deliver, advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL Catheter
Measured: Peri-Procedural
Technical Success (Final)
Defined as final residual stenosis of ≤30% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core laboratory
Measured: Peri-Procedural
Major Adverse Events (MAEs) at 6-months Post Procedure
Major Adverse Events (MAEs) at 6 months defined as a composite of:
- Cardiovascular Death
- Clinically-driven Target Lesion Revascularization
- Unplanned Target Limb Amputation (Above the Ankle)
Measured: 6 Months Post-Procedure
MAEs at 12-months Post Procedure
Major Adverse Events (MAEs) at 12 months defined as a composite of:
- Cardiovascular Death
- Clinically-driven Target Lesion Revascularization
- Unplanned Target Limb Amputation (Above the Ankle)
Measured: 12 Months Post-Procedure
Primary Patency at 12 Months
Primary patency for Above-the-Knee (ATK) lesions is defined as freedom from ≥50% restenosis as determined by DUS and freedom from CD-TLR at 12 months post-procedure.
Primary patency for Below-the-Knee (BTK) lesions is defined as freedom from total occlusion (100% diameter stenosis by DUS) in all target lesions within a flow pathway and freedom from CD-TLR at 12 months post-procedure.
Measured: 12 Months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start16 Mar 2022
- Primary completion19 Dec 2023
- Study completion5 Dec 2024
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
- Device feasibility
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058456
- Sponsor's protocol ID
- CP 65324
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2021
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Single-arm Feasibility Study of the Shockwave Medical Mini S Peripheral Intravascular Lithotripsy (IVL) System
- ClinicalTrials.gov ID
- NCT05058456
- Acronym / sponsor ID
- CP 65324
- 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
- 16 Mar 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Posted 8 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, single-arm feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Device: Shockwave Medical Mini S Peripheral IVL Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -General Inclusion Criteria
- Age of subject is ≥ 18 years.
- Subject is able and willing to comply with all assessments in the study.
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
- Estimated life expectancy > 1 year.
Key exclusion criteria (26 listed)
- General Exclusion Criteria
- Rutherford Clinical Category 0, 1 and 6 (target limb).
- History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure. Note: inflow treatment of non-target lesions is allowed providing successful treatment.
- Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
- Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
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 Medical Mini S Peripheral IVL CatheterThe Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature. | Device | Single-arm |
Primary outcome
Primary Safety: Major Adverse Events (MAE)
Time frame: 30 days
Major Adverse Events (MAE) at 30 days defined as a composite of: * Cardiovascular Death * Clinically Driven Target Lesion Revascularization (CD-TLR) * Unplanned Target Limb Major Amputation (Above the Ankle)
Primary Performance: Technical Success
Time frame: Peri-Procedural
Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core lab
7 secondary outcomes
Serious Angiographic Complications
Time frame: Peri-Procedural
IVL Technical Success (Post- Dilatation)
Time frame: Peri-Procedural
IVL Device Success
Time frame: Peri-Procedural
Technical Success (Final)
Time frame: Peri-Procedural
Major Adverse Events (MAEs) at 6-months Post Procedure
Time frame: 6 Months Post-Procedure
MAEs at 12-months Post Procedure
Time frame: 12 Months Post-Procedure
Primary Patency at 12 Months
Time frame: 12 Months post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave Medical Mini S Peripheral IVL Catheter in people with Peripheral Arterial Disease, run by Shockwave Medical, Inc. at 4 sites in 2 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 12 inclusion and 26 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 3 Aug 2026. 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 Australia, 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 8 Jun 2025). 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?
Primary Safety: 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 3 Aug 2026.