Investigational Study of SWM-831 to Treat Moderate and Severely Calcified Femoropopliteal Arteries

NCT06938854 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: CP 71411jRCT2032240613
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 10

Brief Summary

Disrupt PAD Japan is a prospective, multi-center, single-arm study of SWM-831 to treat moderate and severely calcified femoropopliteal arteries, prior to DCB or stenting.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

• Percentage of Subjects with Procedural Success

  Primary Endpoint for Femoropopliteal: Procedural success is defined as residual stenosis \< 50% without ≥ grade D dissections, prior to Drug-Coated Balloon (DCB) or stenting for the treated target lesion (core lab assessed)

  Day 0

• Percentage of Subjects with Procedural Success

  Primary Endpoint for Iliac: Procedural success is defined as residual stenosis \< 50% without ≥ grade D dissections, prior to stenting for the treated target lesion (core lab assessed)

  Day 0

• Percentage of Subjects with Procedural Success

  Primary Endpoint for BTK: Procedural success is defined as final residual stenosis \< 50% without ≥ grade D dissections for the treated target lesion (core lab assessed).

  Day 0

Secondary Outcomes (7)

• Rate of ≥ grade D dissections, perforation, distal embolization, slow flow or acute vessel closure

  Day 0

• Residual stenosis < 50% without ≥ grade D dissections

  Day 0

• Residual stenosis < 30% without ≥ grade D dissections

  Day 0

• Number of participants with freedom from clinically-driven target lesion revascularization (CD-TLR) CEC adjudicated and freedom from restenosis as determined by duplex-derived peak systolic velocity ratio (PSVR) ≤ 2.4, assessed by the DUS core lab.

  At 6 months and 12 months post-procedure

• Number of participants with Major Adverse Event

  At 30 days, 6 months and 12 months post-procedure

Study Arms (1)

Femoropopliteal Artery

EXPERIMENTAL

Up to 60 subjects with moderate or severely calcified femoropopliteal artery disease at up to 10 sites in Japan will be enrolled in the femoropopliteal clinical study. Destination therapy may include DCB or Stent based on post IVL assessment. In addition, a minimum of 10 and a maximum of 15 subjects with moderately or severely calcified iliac artery disease and a minimum of 10 and a maximum of 15 subjects with moderately or severely calcified BTK artery disease will also be enrolled to assess the safety and effectiveness of IVL in these two cohorts.

Device: Peripheral Intravascular Lithotripsy (IVL)

Interventions

Peripheral Intravascular Lithotripsy (IVL) DEVICE

For the Disrupt PAD Japan study, the Shockwave Medical Peripheral IVL System (SWM-831) is intended for lithotripsy enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the femoropopliteal arteries.

Also known as: Intravascular Lithotripsy (IVL)

Femoropopliteal Artery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age of subject is ≥ 18. Note: If a subject is under 20 years, voluntary agreement shall be obtained from both the subject and the subject's representative or legal guardian using the written consent form.
• Rutherford Clinical Category 2, 3, 4, or 5 of the target limb.
• Estimated life expectancy \> 1 year.
• One target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery). \<Not applicable to iliac or BTK cohort\>
• Target lesion reference vessel diameter (RVD) is between 4.0 mm and 8.0 mm by investigator visual estimate. \<Not applicable to iliac or BTK cohort\>
• 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.
• Subject has at least one patent tibial vessel on the target limb with runoff to the foot, defined as no stenosis ≥ 50%.
• Calcification is determined to be grade 2 - 4 (unilateral calcification ≥ 5 cm, bilateral wall calcification \< 5 cm, and bilateral calcification ≥ 5 cm, respectively), as defined by PACSS (Peripheral Artery Calcification Scoring System). \<Not applicable to iliac and BTK cohort\>
• Target lesion located in the native, de novo common or external iliac artery.
• Target lesion reference vessel diameter (RVD) is between 5.0 mm and 10.0 mm by investigator visual estimate.
• Evidence of PACSS calcification grade 2 - 4 and non-dilatable lesion indicating presence of calcium.
• Note: Non-dilatable lesion requires attempted treatment with PTA during the index procedure with residual stenosis ≥ 50% and no serious angiographic complication.

You may not qualify if:

• Rutherford Clinical Category 0, 1 and 6.
• Subject has known or suspected active infection evidenced by WBC \> 14.0 (14000/mm3) within 14 days prior to index procedure.
• Previous or planned target limb major amputation (above the ankle).
• History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure.
• Note: Inflow treatment of non-target lesions is allowed provided 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.
• History of myocardial infarction within 60 days prior to enrollment.
• History of stroke within 60 days prior to enrollment.
• History of thrombolytic therapy within two weeks prior to enrollment.
• Subject has acute or chronic renal disease with creatinine \> 2.5 mg/dL, unless 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.

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead
• Iqvia Pty Ltd: collaborator
• Yale University: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (10)

Asahi General Hospital

Asahi, Chiba, 289-2511, Japan

Location

Tokyobay Urayasu Ichikawa

Chiba, Japan

Location

Matsuyama Red Cross Hospital

Ehime, Japan

Location

Kokura Memorial Hospital

Fukuoka, Japan

Location

Caress Sapporo Tokeidai Memorial Hospital

Hokkaido, Japan

Location

Tokushukai Shonan Kamakura General Hospital

Kanagawa, Japan

Location

Sendai Kousei Hospital

Miyagi, Japan

Location

Nara Medical University Hospital

Nara, Japan

Location

Osaka International Medical & Science Center Daini Osaka Police Hospital

Osaka, Japan

Location

Toho University Ohashi Medical Center

Tokyo, Japan

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The objective of the study is to assess the safety and effectiveness of IVL to treat moderate and severely calcified femoropopliteal arteries, prior to DCB or stenting.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 22, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (10)