Peripheral Artery DiseaseNCT05007925
Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
A study testing Intravascular Lithotripsy in people with Peripheral Artery Disease, run by Shockwave Medical, Inc. at 43 sites in 2 countries.
Trial summary
To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries. Post-market, prospective , multi-center, single-arm study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Intravascular Lithotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 43 sitesin 2 countries
- Study dates
- 18 Nov 2021to 27 Mar 2026
- 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.
- 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.
- Critical limb ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4-5; or Rutherford 3 in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure.
- Estimated life expectancy >1 year.
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- Angiographic Inclusion Criteria
- Up to 2 below-the-knee target lesion(s) in native vessels in one or both limbs.
- Target lesion reference vessel diameter (RVD) between 2.0 mm and 4.0 mm by investigator visual estimate.
- Target lesion with ≥70% stenosis by investigator visual estimate.
- Target lesion length is ≤200 mm by investigator visual estimate. Target lesion can be all or part of the 200 mm treated zone.
- Distal reconstitution of at least one pedal vessel (<50% stenosis) (desert foot excluded).
- Evidence of at least moderate calcification at the target lesion site by angiography/IVUS OR non-dilatable lesion indicating presence of calcium. Must meet one of the following:
- Angiography requires fluoroscopic evidence of calcification on parallel sides of the vessel and extending > 50% the length of the lesion.
- IVUS requires presence of ≥270 degrees of calcium over the course of at least 10mm.
- Non-dilatable lesion requires attempted treatment with PTA during the index procedure with residual stenosis > 50% and no serious angiographic complications.
Who cannot join
- General Exclusion Criteria
- Rutherford Category 0, 1, 2 or 6 (target limb).
- Osteomyelitis or deep soft tissue infection extending proximal from the metatarsals that cannot be treated with an individual toe ray amputation or transmetatarsal amputation (TMA) .
- History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure.
- 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.
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- Subject has known allergy to urethane, nylon, or silicone.
- Myocardial infarction within 30 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 90 days.
- The planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesions during the index procedure.
- Planned major amputation (of either leg).
- Acute limb ischemia.
- Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).
- Subject has an anticipated life span of less than one (1) year.
- 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 prior to treatment of target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism ).
- Failed PTA in target lesion during index procedure with angiographic evidence of serious angiographic complications .
- 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
43 sites in 2 countries.
43 sites in 2 countries
United States39 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756
Ascension St Johns Heart & Vascular Center
Bartlesville, Oklahoma, 74006
McLaren Bay Heart and Vascular
Bay City, Michigan, 48708
Massachusetts General Hospital
Boston, Massachusetts, 02114
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Charlotte Radiology
Charlotte, North Carolina, 28202
Rush University Medical Center
Chicago, Illinois, 60612
The Christ Hospital
Cincinnati, Ohio, 45219
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Ohio Health Research Institute
Columbus, Ohio, 43214
Texas Health Presbyterian Hospital
Dallas, Texas, 75231
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
UCSF Fresno
Fresno, California, 93720
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17101
St. Luke's Hospital
Kansas City, Missouri, 64111
Wellmont Cardiology Services dba CVA Heart Institute
Kingsport, Tennessee, 37660
Scripps Memorial Hospital
La Jolla, California, 92037
McLaren Greater Lansing
Lansing, Michigan, 48910
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Southcoast Hospitals Group
New Bedford, Massachusetts, 02740
NYU Langone Health
New York, New York, 10016
NYU Langone Medical Center
New York, New York, 10016
Mt. Sinai Hospital
New York, New York, 10029
Columbia University Irving Medical Center/NYPH
New York, New York, 10032
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Medstar Montgomery Medical Center
Olney, Maryland, 20832
Stanford Hospital
Palo Alto, California, 94304
Baylor Scott & White - The Heart Hospital Baylor
Plano, Texas, 75093
The Miriam Hospital
Providence, Rhode Island, 02906
North Carolina Heart & Vascular
Raleigh, North Carolina, 27607
UC Davis Health
Sacramento, California, 95817
VA Puget Sound Health Care Systems - Seattle
Seattle, Washington, 98108
Barnes-Jewish Hospital
St Louis, Missouri, 63110
St. Helena Hospital
St. Helena, California, 94574
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
North Mississippi Medical Center
Tupelo, Mississippi, 38801
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Germany4 sites
Karolinen-Hospital Hüsten
Arnsberg, 59759
Universitäts-Herzzentrum Freiburg & Bad Krozingen
Bad Krozingen, 79189
Universitätsklinikum der Ruhr-Universitaet Bochum
Bad Oeynhausen, 32545
Universitätsklinikum Leipzig AoR
Leipzig, 04103
About this study
Official title: Prospective, Multi-center, Single-arm Study of the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System for Treatment of Calcified Peripheral Arterial Disease (PAD) in Below-the-Knee (BTK) Arteries
To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries.
Post-market, prospective , multi-center, single-arm study.
- Conditions
- Peripheral Artery Disease
- Being tested
- Intravascular Lithotripsy
- 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.
Intravascular LithotripsyDevice
Localized peripheral intravascular lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Not described Receives: Device: Intravascular Lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Procedure Success
Procedure Success defined as ≤50% residual stenosis for all treated target lesions without serious angiographic complications (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab at the final timepoint.
Measured: 30 days
Number of Participants With Major Adverse Limb Events (MALE) + Post-Operative Death (POD)
Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days defined as a composite of:
- all-cause death
- above-ankle amputation of the index limb
- major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery
Measured: 30 days
Subjects Without Serious Angiographic Complications
Subject Success defined as final residual stenosis ≤ 50% in the target lesion without serious angiographic complications as assessed by the angiographic core lab. Serious angiographic complications include (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab
Measured: 30 days
Secondary outcomes (9)
Number of Lesions With Technical Success
Lesion Success defined as final residual stenosis ≤50% in the target lesion without serious angiographic complications as assessed by the angiographic core lab
Measured: 30 days
Number of Patients With Primary Patency
Primary Patency at 6 and 12 months defined as the absence of both total occlusion (100% diameter stenosis by DUS) in all of the target lesions in a flow pathway, as well as a Clinically-Driven Target Lesion Revascularization (CD-TLR)
Measured: 6 and 12 months
Number of Participants Free From Clinically-driven Target Lesion Revascularization (CD-TLR)
Clinically-driven target lesion revascularization (CD-TLR) defined as a composite of:
- CD-TLR
- Major target limb amputation
Measured: 30 days
Number of Participants With Major Adverse Events (MAE)
Major Adverse Events (MAE) at 30 days defined as a composite of:
- Need for emergency surgical revascularization of target limb
- Unplanned target limb major amputation (above the ankle)
- Symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow, and extend hospitalization
- Perforations that require an intervention, including bail-out stenting
Measured: 30 days
VascuQoL Reported as Change From Baseline
The VascuQoL-6 is a short, disease-specific questionnaire used to measure health-related quality of life (HRQoL) in patients with peripheral arterial disease (PAD), specifically those with intermittent claudication and critical limb ischemia.
Measured: 30 days, 6, 12 & 24 months
Ankle-brachial Index (ABI) Reported as Change From Baseline
The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
Measured: 30 days
Rutherford Category Reported as Change From Baseline
The Rutherford classification is a system used to categorize the severity of peripheral artery disease (PAD), specifically chronic limb-threatening ischemia (CLTI), based on symptoms and tissue loss. The classification ranges are from Class 0 where no symptoms of PAD are present and the patient has no claudication or tissue loss to Class 6 where patients have extensive tissue loss, including gangrene, that extends above the transmetatarsal level (the area above the bones of the foot). A higher score on the Rutherford Classification Scale is indicative of a worse outcome.
Measured: 30 days
Toe-brachial Index (TBI) Reported as Change From Baseline
The TBI is the ratio of systolic blood pressure measured at the toe to systolic blood pressure at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
Measured: 30 Days
Number of Participants Free From Major Target Limb Amputation
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start18 Nov 2021
- Primary completion25 Mar 2024
- Study completion27 Mar 2026
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery 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
- 250 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
- NCT05007925
- Sponsor's protocol ID
- CP 65007
- Status last verified
- Apr 2026
- First submitted
- 9 Aug 2021
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Chandra V, Lansky AJ, Sayfo S, Shammas NW, Soukas P, Park J, Siah M, Babaev A, Shields R, West NEJ, Armstrong E. Thirty-day outcomes from the Disrupt PAD BTK II study of the Shockwave Intravascular Lithotripsy System for treatment of calcified below-the-knee peripheral arterial disease. J Vasc Surg. 2025 Mar;81(3):710-719.e2. doi: 10.1016/j.jvs.2024.11.003. Epub 2024 Nov 12.
PubMed 39536842
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Single-arm Study of the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System for Treatment of Calcified Peripheral Arterial Disease (PAD) in Below-the-Knee (BTK) Arteries
- ClinicalTrials.gov ID
- NCT05007925
- Acronym / sponsor ID
- CP 65007
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Posted 5 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries.
Post-market, prospective , multi-center, single-arm study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Device: Intravascular Lithotripsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- General Inclusion Criteria
- Age of subject is ≥ 18.
- 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.
- Critical limb ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4-5; or Rutherford 3 in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure.
Key exclusion criteria (29 listed)
- General Exclusion Criteria
- Rutherford Category 0, 1, 2 or 6 (target limb).
- Osteomyelitis or deep soft tissue infection extending proximal from the metatarsals that cannot be treated with an individual toe ray amputation or transmetatarsal amputation (TMA) .
- History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure.
- Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
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 |
|---|---|---|
| Intravascular LithotripsyLocalized peripheral intravascular lithotripsy | Device | Single-arm |
Primary outcome
Number of Participants With Procedure Success
Time frame: 30 days
Procedure Success defined as ≤50% residual stenosis for all treated target lesions without serious angiographic complications (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab at the final timepoint.
Number of Participants With Major Adverse Limb Events (MALE) + Post-Operative Death (POD)
Time frame: 30 days
Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days defined as a composite of: * all-cause death * above-ankle amputation of the index limb * major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery
Subjects Without Serious Angiographic Complications
Time frame: 30 days
Subject Success defined as final residual stenosis ≤ 50% in the target lesion without serious angiographic complications as assessed by the angiographic core lab. Serious angiographic complications include (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab
9 secondary outcomes
Number of Lesions With Technical Success
Time frame: 30 days
Number of Patients With Primary Patency
Time frame: 6 and 12 months
Number of Participants Free From Clinically-driven Target Lesion Revascularization (CD-TLR)
Time frame: 30 days
Number of Participants With Major Adverse Events (MAE)
Time frame: 30 days
VascuQoL Reported as Change From Baseline
Time frame: 30 days, 6, 12 & 24 months
Ankle-brachial Index (ABI) Reported as Change From Baseline
Time frame: 30 days
Rutherford Category Reported as Change From Baseline
Time frame: 30 days
Toe-brachial Index (TBI) Reported as Change From Baseline
Time frame: 30 Days
Number of Participants Free From Major Target Limb Amputation
Time frame: 30 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39536842Chandra V, Lansky AJ, Sayfo S, Shammas NW, Soukas P, Park J, Siah M, Babaev A, Shields R, West NEJ, Armstrong E. Thirty-day outcomes from the Disrupt PAD BTK II study of the Shockwave Intravascular Lithotripsy System for treatment of calcified below-the-knee peripheral arterial disease. J Vasc Surg. 2025 Mar;81(3):710-719.e2. doi: 10.1016/j.jvs.2024.11.003. Epub 2024 Nov 12.
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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.
43 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular Lithotripsy in people with Peripheral Artery Disease, run by Shockwave Medical, Inc. at 43 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 16 inclusion and 29 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Germany. 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 5 Aug 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?
Number of Participants With Procedure Success (time frame: 30 days). The study lists 3 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 NCT05007925, 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 5 May 2026.