This study is accepting new patients by invitation only
Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
a study on Peripheral Arterial Disease
- for people ages 18 years and up (full criteria)
- at Fresno, California and other locations
- study startedestimated completion
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.
Prospective, Multi-center, Single-arm Study of the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System for Treatment of Calcified Peripheral Arterial Disease (PAD) in Below-the-Knee (BTK) Arteries
Peripheral Artery Disease, Peripheral Arterial Disease, Intravascular Lithotripsy
You can join if…
Open to people ages 18 years and up
- General 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.
- Angiographic Inclusion Criteria
- 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.
- Target lesion length is ≤200 mm by investigator visual estimate. Target lesion can be all or part of the 200 mm treated zone.
- Distal reconstitution of at least one pedal vessel (<50% stenosis) (desert foot excluded).
- 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:
- Angiography requires fluoroscopic evidence of calcification on parallel sides of the vessel and extending > 50% the length of the lesion.
- IVUS requires presence of ≥270 degrees of calcium over the course of at least 10mm.
- Non-dilatable lesion requires attempted treatment with PTA during the index procedure with residual stenosis > 50% and no serious angiographic complications.
You CAN'T join if...
- General 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.
- Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy.
- 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.
- Covid-19 diagnosis within 90 days.
- The planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesions during the index procedure.
- Planned major amputation (of either leg).
- Acute limb ischemia.
- Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).
- Subject has an anticipated life span of less than one (1) year.
- Subject already enrolled into this study.
- Angiographic Exclusion Criteria
- 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).
- 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 ).
- Failed PTA in target lesion during index procedure with angiographic evidence of serious angiographic complications .
- Target lesion includes in-stent restenosis.
- Evidence of aneurysm or thrombus in target vessel.
- No calcium or mild calcium in the target lesion.
- Target lesion within native or synthetic vessel grafts.
- 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.
- UCSF Fresno
Fresno California 93720 United States
- Stanford Hospital
Palo Alto California 94304 United States
- accepting new patients by invitation only
- Start Date
- Completion Date
- Shockwave Medical, Inc.
- Study Type
- Expecting 250 study participants
- Last Updated