Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
- Conditions
- Peripheral Artery Disease
- Interventions
- Device: Intravascular Lithotripsy
- Registration Number
- NCT05007925
- Lead Sponsor
- Shockwave Medical, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 250
- General Inclusion Criteria
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Age of subject is ≥ 18.
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Subject is able and willing to comply with all assessments in the study.
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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.
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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.
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Estimated life expectancy >1 year.
- Angiographic Inclusion Criteria
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Up to 2 below-the-knee target lesion(s) in native vessels in one or both limbs.
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Target lesion reference vessel diameter (RVD) between 2.0 mm and 4.0 mm by investigator visual estimate.
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Target lesion with ≥70% stenosis by investigator visual estimate.
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Target lesion length is ≤200 mm by investigator visual estimate. Target lesion can be all or part of the 200 mm treated zone.
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Distal reconstitution of at least one pedal vessel (<50% stenosis) (desert foot excluded).
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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.
- General Exclusion Criteria
-
Rutherford Category 0, 1, 2 or 6 (target limb).
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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) .
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History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure.
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Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
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Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
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Subject has known allergy to urethane, nylon, or silicone.
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Myocardial infarction within 30 days prior to enrollment.
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History of stroke within 60 days prior to enrollment.
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Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy.
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Subject is pregnant or nursing.
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Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
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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.
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Covid-19 diagnosis within 90 days.
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The planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesions during the index procedure.
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Planned major amputation (of either leg).
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Acute limb ischemia.
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Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).
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Subject has an anticipated life span of less than one (1) year.
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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).
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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 ).
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Failed PTA in target lesion during index procedure with angiographic evidence of serious angiographic complications .
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Target lesion includes in-stent restenosis.
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Evidence of aneurysm or thrombus in target vessel.
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No calcium or mild calcium in the target lesion.
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Target lesion within native or synthetic vessel grafts.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-arm Intravascular Lithotripsy -
- Primary Outcome Measures
Name Time Method Procedure Success At procedure Procedure Success defined as ≤50% residual stenosis for all treated target lesions without serious angiographic complications (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab
Major Adverse Limb Events (MALE) + Post-Operative Death (POD) 30 days Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days defined as a composite of:
* all-cause death
* above-ankle amputation of the index limb
* major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery
- Secondary Outcome Measures
Name Time Method Serious angiographic complications At procedure Serious angiographic complications (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab
Clinically Relevant Target Lesion Failure (CR-TLF) 30 days, 6, 12 & 24 months Clinically Relevant Target Lesion Failure (CR-TLF) at 30 days, 6, 12 \& 24 months defined as a composite of:
* CD-TLR
* Ischemia-related major amputation
* Clinically relevant target lesion occlusionMajor Adverse Events (MAE) 30 days Major Adverse Events (MAE) at 30 days defined as a composite of:
* Need for emergency surgical revascularization of target limb
* Unplanned target limb major amputation (above the ankle)
* Symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow, and extend hospitalization
* Perforations that require an intervention, including bail-out stentingAnkle-brachial index (ABI) or toe-brachial index (TBI) 30 days, 6, 12 & 24 months Ankle-brachial index (ABI) or toe-brachial index (TBI) at 30 days, 6, 12 \& 24 months, reported as change from baseline
Primary Patency 6 and 12 months Primary Patency at 6 and 12 months defined as the absence of both total occlusion (100% diameter stenosis by DUS) in all of the target lesions in a flow pathway, as well as a Clinically-Driven Target Lesion Revascularization (CD-TLR)
VascuQoL 30 days, 6, 12 & 24 months Quality of Life (QoL) assessed by VascuQoL questionnaire at 30 days, 6, 12 \& 24 months, reported as change from baseline
Lesion Success At procedure Lesion Success defined as final residual stenosis ≤50% in the target lesion without significant angiographic complications as assessed by the angiographic core lab
Rutherford Category 30 days, 6, 12 & 24 months Rutherford Category at 30 days, 6, 12 \& 24 months, reported as change from baseline
Trial Locations
- Locations (43)
UCSF Fresno
🇺🇸Fresno, California, United States
Wellmont Cardiology Services dba CVA Heart Institute
🇺🇸Kingsport, Tennessee, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Medstar Montgomery Medical Center
🇺🇸Olney, Maryland, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
VA Puget Sound Health Care Systems - Seattle
🇺🇸Seattle, Washington, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Columbia University Irving Medical Center/NYPH
🇺🇸New York, New York, United States
North Carolina Heart & Vascular
🇺🇸Raleigh, North Carolina, United States
Pinnacle Health Cardiovascular Institute
🇺🇸Harrisburg, Pennsylvania, United States
Karolinen-Hospital Hüsten
🇩🇪Arnsberg, Germany
McLaren Greater Lansing
🇺🇸Lansing, Michigan, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
St. Helena Hospital
🇺🇸Saint Helena, California, United States
Midwest Cardiovascular Research Foundation
🇺🇸Davenport, Iowa, United States
Southcoast Hospitals Group
🇺🇸New Bedford, Massachusetts, United States
McLaren Bay Heart and Vascular
🇺🇸Bay City, Michigan, United States
Charlotte Radiology
🇺🇸Charlotte, North Carolina, United States
Texas Health Presbyterian Hospital
🇺🇸Dallas, Texas, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Mt. Sinai Hospital
🇺🇸New York, New York, United States
Ascension St Johns Heart & Vascular Center
🇺🇸Bartlesville, Oklahoma, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Universitätsklinikum der Ruhr-Universitaet Bochum
🇩🇪Bad Oeynhausen, Germany
Baylor Scott & White - The Heart Hospital Baylor
🇺🇸Plano, Texas, United States
Universitäts-Herzzentrum Freiburg & Bad Krozingen
🇩🇪Bad Krozingen, Germany
Universitätsklinikum Leipzig AoR
🇩🇪Leipzig, Germany
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
Stanford Hospital
🇺🇸Palo Alto, California, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
UC Davis Health
🇺🇸Sacramento, California, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
Cardiothoracic and Vascular Surgeons
🇺🇸Austin, Texas, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States