CompletedNot Applicable

Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System

United States250 participantsStarted 2021-11-18

Plain-language 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.

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

✓. 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.
✓. 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.

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.
✕. 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.

What they're measuring

Number of Participants With Procedure Success

Timeframe: 30 days

Number of Participants With Major Adverse Limb Events (MALE) + Post-Operative Death (POD)

Timeframe: 30 days

Subjects Without Serious Angiographic Complications

Timeframe: 30 days

Trial details

NCT IDNCT05007925

SponsorShockwave Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-25

Results submitted2025-06-12

View on ClinicalTrials.gov More Peripheral Artery 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

✓. 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.
✓. 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.

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.
✕. 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.