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CompletedNCT05007925Updated May 5, 2026Results posted

Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System

An interventional study of Intravascular Lithotripsy in Peripheral Artery Disease, sponsored by Shockwave Medical, Inc.. Completed at 43 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Shockwave Medical, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peripheral Artery Disease
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 250 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Shockwave Medical, Inc. is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

- General Inclusion Criteria

  1. Age of subject is ≥ 18.
  2. Subject is able and willing to comply with all assessments in the study.
  3. 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.
  4. 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.

  5. Estimated life expectancy >1 year.

    • Angiographic Inclusion Criteria
  6. Up to 2 below-the-knee target lesion(s) in native vessels in one or both limbs.
  7. Target lesion reference vessel diameter (RVD) between 2.0 mm and 4.0 mm by investigator visual estimate.
  8. Target lesion with ≥70% stenosis by investigator visual estimate.
  9. Target lesion length is ≤200 mm by investigator visual estimate. Target lesion can be all or part of the 200 mm treated zone.
  10. Distal reconstitution of at least one pedal vessel (\<50% stenosis) (desert foot excluded).

  11. 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:

    1. Angiography requires fluoroscopic evidence of calcification on parallel sides of the vessel and extending > 50% the length of the lesion.
    2. IVUS requires presence of ≥270 degrees of calcium over the course of at least 10mm.
    3. Non-dilatable lesion requires attempted treatment with PTA during the index procedure with residual stenosis > 50% and no serious angiographic complications.

Exclusion criteria

Exclusion Criteria:

- General Exclusion Criteria

  1. Rutherford Category 0, 1, 2 or 6 (target limb).
  2. 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) .
  3. History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure.
  4. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
  5. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  6. Subject has known allergy to urethane, nylon, or silicone.
  7. Myocardial infarction within 30 days prior to enrollment.
  8. History of stroke within 60 days prior to enrollment.
  9. Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy.
  10. Subject is pregnant or nursing.
  11. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
  12. 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.
  13. Covid-19 diagnosis within 90 days.
  14. The planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesions during the index procedure.
  15. Planned major amputation (of either leg).
  16. Acute limb ischemia.
  17. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).
  18. Subject has an anticipated life span of less than one (1) year.

  19. Subject already enrolled into this study.

    • Angiographic Exclusion Criteria
  20. 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).
  21. 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 ).
  22. Failed PTA in target lesion during index procedure with angiographic evidence of serious angiographic complications .
  23. Target lesion includes in-stent restenosis.
  24. Evidence of aneurysm or thrombus in target vessel.
  25. No calcium or mild calcium in the target lesion.
  26. Target lesion within native or synthetic vessel grafts.
  27. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    Single-arm

    Device: Intravascular Lithotripsy

Interventions

  • DeviceIntravascular Lithotripsy

    Localized peripheral intravascular lithotripsy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

  2. 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

    Time frame: 30 days

  3. 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

    Time frame: 30 days

Secondary outcomes

  1. 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

    Time frame: 30 days

  2. 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)

    Time frame: 6 and 12 months

  3. 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

    Time frame: 30 days

  4. 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

    Time frame: 30 days

  5. 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.

    Time frame: 30 days, 6, 12 & 24 months

  6. 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.

    Time frame: 30 days

  7. 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.

    Time frame: 30 days

  8. 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.

    Time frame: 30 Days

  9. Number of Participants Free From Major Target Limb Amputation

    Time frame: 30 Days

07

Results

Posted Aug 5, 2025

Participant flow

Participant flow — Overall Study
MilestoneDisrupt PAD BTK II
Started250
Completed242
Not completed8

Outcome measures

PrimaryNumber 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.

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants With Procedure Success
ParticipantsShockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
Number of Participants With Procedure Success232
PrimaryNumber 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

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants With Major Adverse Limb Events (MALE) + Post-Operative Death (POD)
ParticipantsShockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
Number of Participants With Major Adverse Limb Events (MALE) + Post-Operative Death (POD)2
PrimarySubjects 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

Time frame:
30 days
Reported as:
Count of participants · Participants
Subjects Without Serious Angiographic Complications
ParticipantsShockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
Subjects Without Serious Angiographic Complications234
SecondaryNumber 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

Time frame:
30 days
Reported as:
Number · Lesions
Number of Lesions With Technical Success
LesionsShockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
Lesion Success285
Freedom From Any Serious Angiographic Complications287
Residual Stenosis ≤ 50%287
SecondaryNumber 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)

Time frame:
6 and 12 months

Results for this outcome have not been posted.

SecondaryNumber 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

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants Free From Clinically-driven Target Lesion Revascularization (CD-TLR)
ParticipantsShockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
Number of Participants Free From Clinically-driven Target Lesion Revascularization (CD-TLR)242
SecondaryNumber 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

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants With Major Adverse Events (MAE)
ParticipantsShockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
Number of Participants With Major Adverse Events (MAE)5
SecondaryVascuQoL 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.

Time frame:
30 days, 6, 12 & 24 months

Results for this outcome have not been posted.

SecondaryAnkle-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.

Time frame:
30 days
Reported as:
Mean · ratio
Ankle-brachial Index (ABI) Reported as Change From Baseline
ratioShockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
Ankle-brachial Index (ABI) Reported as Change From Baseline0.2 ± 0.3
SecondaryRutherford 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.

Time frame:
30 days
Reported as:
Count of participants · Participants
Rutherford Category Reported as Change From Baseline
ParticipantsShockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
1-Mild Claudication21
2-Moderate Claudication14
3-Severe Claudication11
4-Ischemic Rest Pain10
5- Minor Tissue Loss102
6-Ulceration Or Gangrene1
0-Asymptomatic68
SecondaryToe-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.

Time frame:
30 Days
Reported as:
Mean · ratio
Toe-brachial Index (TBI) Reported as Change From Baseline
ratioShockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
Toe-brachial Index (TBI) Reported as Change From Baseline0.2 ± 0.2
SecondaryNumber of Participants Free From Major Target Limb Amputation
Time frame:
30 Days
Reported as:
Count of participants · Participants
Number of Participants Free From Major Target Limb Amputation
ParticipantsShockwave Medical M5, M5+, S4 Peripheral Intravascular Lithotripsy System
Number of Participants Free From Major Target Limb Amputation240

Adverse events

Collected over This accounting is for all study events through the 30-day time frame.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Disrupt PAD BTK II1/250 (0.4%)67/250 (26.8%)131/250 (52.4%)
Most frequent serious events
Showing 10 of 61
Most frequent serious events
EventDisrupt PAD BTK II
Vascular procedure complicationInjury, poisoning and procedural complications13/250
OsteomyelitisInfections and infestations8/250
Impaired healingGeneral disorders7/250
GangreneInfections and infestations6/250
Peripheral arterial occlusive diseaseVascular disorders6/250
AnaemiaBlood and lymphatic system disorders4/250
Limb injuryInjury, poisoning and procedural complications4/250
Cardiac failure congestiveCardiac disorders3/250
SepsisInfections and infestations3/250
Acute respiratory failureRespiratory, thoracic and mediastinal disorders3/250
Most frequent other events
Showing 10 of 20
Most frequent other events
EventDisrupt PAD BTK II
Vascular procedure complicationInjury, poisoning and procedural complications59/250
Limb injuryInjury, poisoning and procedural complications10/250
OsteomyelitisInfections and infestations8/250
Impaired healingGeneral disorders7/250
GangreneInfections and infestations7/250
FallInjury, poisoning and procedural complications6/250
AnaemiaBlood and lymphatic system disorders4/250
Peripheral swellingGeneral disorders4/250
HaematomaVascular disorders4/250
Cardiac failure congestiveCardiac disorders3/250

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Disrupt PAD BTK II
<=18 years0
Between 18 and 65 years63
>=65 years187
Age, Continuous
Age, Continuous(years)Disrupt PAD BTK II
Mean71.6 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)Disrupt PAD BTK II
Female68
Male182
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Disrupt PAD BTK II
American Indian or Alaska Native0
Asian4
Native Hawaiian or Other Pacific Islander2
Black or African American45
White181
Unknown or Not Reported14
Other4
Region of Enrollment
Region of Enrollment(participants)Disrupt PAD BTK II
United States239
Germany11
08

Study locations

43 sites
  • UCSF Fresno
    Fresno, California 93720, United States
  • Scripps Memorial Hospital
    La Jolla, California 92037, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • Stanford Hospital
    Palo Alto, California 94304, United States
  • UC Davis Health
    Sacramento, California 95817, United States
  • St. Helena Hospital
    St. Helena, California 94574, United States
  • MedStar Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
  • Tallahassee Memorial Hospital
    Tallahassee, Florida 32308, United States
  • Piedmont Heart Institute
    Atlanta, Georgia 30309, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Midwest Cardiovascular Research Foundation
    Davenport, Iowa 52803, United States
  • Medstar Montgomery Medical Center
    Olney, Maryland 20832, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Southcoast Hospitals Group
    New Bedford, Massachusetts 02740, United States
  • McLaren Bay Heart and Vascular
    Bay City, Michigan 48708, United States
  • McLaren Greater Lansing
    Lansing, Michigan 48910, United States
  • North Mississippi Medical Center
    Tupelo, Mississippi 38801, United States
  • St. Luke's Hospital
    Kansas City, Missouri 64111, United States
  • Barnes-Jewish Hospital
    St Louis, Missouri 63110, United States
  • NYU Langone Health
    New York, New York 10016, United States
  • NYU Langone Medical Center
    New York, New York 10016, United States
  • Mt. Sinai Hospital
    New York, New York 10029, United States
  • Columbia University Irving Medical Center/NYPH
    New York, New York 10032, United States
  • Charlotte Radiology
    Charlotte, North Carolina 28202, United States
  • North Carolina Heart & Vascular
    Raleigh, North Carolina 27607, United States
  • The Christ Hospital
    Cincinnati, Ohio 45219, United States
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
  • Ohio Health Research Institute
    Columbus, Ohio 43214, United States
  • Ascension St Johns Heart & Vascular Center
    Bartlesville, Oklahoma 74006, United States
  • Bryn Mawr Hospital
    Bryn Mawr, Pennsylvania 19010, United States
  • Pinnacle Health Cardiovascular Institute
    Harrisburg, Pennsylvania 17101, United States
  • The Miriam Hospital
    Providence, Rhode Island 02906, United States
  • Medical University of South Carolina (MUSC)
    Charleston, South Carolina 29425, United States
  • Wellmont Cardiology Services dba CVA Heart Institute
    Kingsport, Tennessee 37660, United States
  • Cardiothoracic and Vascular Surgeons
    Austin, Texas 78756, United States
  • Texas Health Presbyterian Hospital
    Dallas, Texas 75231, United States
  • Baylor Scott & White - The Heart Hospital Baylor
    Plano, Texas 75093, United States
  • Sentara Norfolk General Hospital
    Norfolk, Virginia 23507, United States
  • VA Puget Sound Health Care Systems - Seattle
    Seattle, Washington 98108, United States
  • Karolinen-Hospital Hüsten
    Arnsberg, 59759, Germany
  • Universitäts-Herzzentrum Freiburg & Bad Krozingen
    Bad Krozingen, 79189, Germany
  • Universitätsklinikum der Ruhr-Universitaet Bochum
    Bad Oeynhausen, 32545, Germany
  • Universitätsklinikum Leipzig AoR
    Leipzig, 04103, Germany
09

References and documents

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 documents

  • Protocol and statistical analysis plan · Aug 22, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05007925
Lead sponsor
Shockwave Medical, Inc.
Responsible party
Sponsor
First posted
Aug 17, 2021
Start date
Nov 18, 2021
Primary completion
Mar 25, 2024
Completion
Mar 27, 2026
Results posted
Aug 5, 2025
Last update
May 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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