Active — Not RecruitingNot Applicable

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

Japan81 participantsStarted 2025-03-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Percentage of Subjects with Procedural Success

Timeframe: Day 0

Percentage of Subjects with Procedural Success

Timeframe: Day 0

Percentage of Subjects with Procedural Success

Timeframe: Day 0

Trial details

NCT IDNCT06938854

SponsorShockwave Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-31

View on ClinicalTrials.gov More Peripheral Arterial Disease trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. 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.