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

NCT ID: NCT06938854

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2028-03-01

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.

Detailed Description

Up to 60 subjects at up to 10 sites in Japan will be enrolled in the femoropopliteal clinical study with moderate and severely calcified femoropopliteal artery disease presenting with Rutherford Category 2 - 5 of the target limb.

Two additional cohorts [Iliac and BTK (Below-the-Knee)] will enroll a minimum of 10 and a maximum of 15 subjects each with moderate and severely calcified iliac disease with a Rutherford Category (RC) 2 - 5 and a minimum of 10 and a maximum of 15 subjects with moderate and severely calcified BTK lesions with a Rutherford Category (RC) 2 - 5 will be enrolled and followed through 12 months.

The estimated study duration for these cohorts is approximately 24 months. Study subjects will be followed through discharge, 30 days, 6, and 12 months.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Femoropopliteal Artery

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.

Group Type: EXPERIMENTAL

Peripheral Intravascular Lithotripsy (IVL)

Intervention Type: 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.

Interventions

Peripheral Intravascular Lithotripsy (IVL)

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.

Intervention Type: DEVICE

Other Intervention Names

Intravascular Lithotripsy (IVL)

Eligibility Criteria

Inclusion Criteria

1. Subject is able and willing to comply with all assessments in the study.

2. 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.

3. 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.

4. Rutherford Clinical Category 2, 3, 4, or 5 of the target limb.

5. Estimated life expectancy > 1 year.

1. 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>

2. 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>

3. Target lesion with ≥ 70% stenosis by investigator visual estimate.

4. Target lesion length is ≤ 200 mm by investigator visual estimate. Target lesion can be all or part of the 200 mm treated zone.

5. Subject has at least one patent tibial vessel on the target limb with runoff to the foot, defined as no stenosis ≥ 50%.

6. 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>

1. Target lesion located in the native, de novo common or external iliac artery.

2. Target lesion reference vessel diameter (RVD) is between 5.0 mm and 10.0 mm by investigator visual estimate.

3. 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.

1. Target lesion from the native, de novo distal segment of the popliteal artery to the ankle joint.

2. Target lesion reference vessel diameter (RVD) is between 2.0 mm and 4.0 mm by investigator visual estimate.

3. 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.

Exclusion Criteria

1. Rutherford Clinical Category 0, 1 and 6.

2. Subject has known or suspected active infection evidenced by WBC > 14.0 (14000/mm3) within 14 days prior to index procedure.

3. Previous or planned target limb major amputation (above the ankle).

4. 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.

5. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.

6. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.

7. Subject has known allergy to urethane, nylon, or silicone.

8. History of myocardial infarction within 60 days prior to enrollment.

9. History of stroke within 60 days prior to enrollment.

10. History of thrombolytic therapy within two weeks prior to enrollment.

11. Subject has acute or chronic renal disease with creatinine > 2.5 mg/dL, unless on dialysis.

12. Subject is pregnant or nursing.

13. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.

14. 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.

15. The use of specialty balloons, re-entry or atherectomy devices.

16. Active COVID-19 or previously diagnosed COVID-19 with sequelae that could confound endpoint assessments.

17. Subject has an anticipated life span of less than one (1) year.

1. Subjects with osteomyelitis or deep soft tissue infection in the target limb.

2. Acute limb ischemia (of either leg).

3. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot) in the target limb.

1. In-stent restenosis within 10 mm of the target lesion.

2. Lesion within 10 mm of the ostium of the SFA or within 10 mm proximal to the anterior tibial artery ostium. <Not applicable to iliac or BTK cohort>

3. Evidence of aneurysm or thrombus in target vessel.

4. No calcium or mild calcium in the target lesion by PACSS.

5. Target lesion within native or synthetic vessel grafts.

6. Subject has significant stenosis (≥ 50% stenosis) or occlusion of inflow tract before target treatment zone (e.g., iliac or common femoral) not successfully treated.

7. Failure to successfully treat significant distal non-target lesions, if treated prior to target lesion. Successful treatment is defined as obtaining < 50% residual stenosis with no serious angiographic complications (e.g., embolism).

8. 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.

1.Target lesion with any aorta involvement.

1. 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).

2. Treatment of vessels below the ankle joint.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iqvia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Shockwave Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asahi General Hospital

Asahi, Chiba, Japan

Tokyobay Urayasu Ichikawa

Chiba, , Japan

Matsuyama Red Cross Hospital

Ehime, , Japan

Kokura Memorial Hospital

Fukuoka, , Japan

Caress Sapporo Tokeidai Memorial Hospital

Hokkaido, , Japan

Tokushukai Shonan Kamakura General Hospital

Kanagawa, , Japan

Sendai Kousei Hospital

Miyagi, , Japan

Nara Medical University Hospital

Nara, , Japan

Osaka International Medical & Science Center Daini Osaka Police Hospital

Osaka, , Japan

Toho University Ohashi Medical Center

Tokyo, , Japan

Countries

Japan

Other Identifiers

jRCT2032240613

Identifier Type: OTHER

Identifier Source: secondary_id

CP 71411

Identifier Type: -

Identifier Source: org_study_id