Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System

Not Applicable

Active, not recruiting

Conditions: Peripheral Artery Disease

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

Inclusion Criteria

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:
1. Angiography requires fluoroscopic evidence of calcification on parallel sides of the vessel and extending > 50% the length of the lesion.
2. IVUS requires presence of ≥270 degrees of calcium over the course of at least 10mm.
3. Non-dilatable lesion requires attempted treatment with PTA during the index procedure with residual stenosis > 50% and no serious angiographic complications.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Procedure Success	30 days	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 at the final timepoint.
Number of Participants With 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
Subjects Without Serious Angiographic Complications	30 days	Subject Success defined as final residual stenosis ≤ 50% in the target lesion without serious angiographic complications as assessed by the angiographic core lab. Serious angiographic complications include (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab

Secondary Outcome Measures

Name	Time	Method
Number of Lesions With Technical Success	30 days	Lesion Success defined as final residual stenosis ≤50% in the target lesion without serious angiographic complications as assessed by the angiographic core lab
Number of Patients With 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)
Number of Participants Free From Clinically-driven Target Lesion Revascularization (CD-TLR)	30 days	Clinically-driven target lesion revascularization (CD-TLR) defined as a composite of: * CD-TLR * Major target limb amputation
Number of Participants With Major 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 stenting
VascuQoL Reported as Change From Baseline	30 days, 6, 12 & 24 months	The VascuQoL-6 is a short, disease-specific questionnaire used to measure health-related quality of life (HRQoL) in patients with peripheral arterial disease (PAD), specifically those with intermittent claudication and critical limb ischemia.
Ankle-brachial Index (ABI) Reported as Change From Baseline	30 days	The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
Rutherford Category Reported as Change From Baseline	30 days	The Rutherford classification is a system used to categorize the severity of peripheral artery disease (PAD), specifically chronic limb-threatening ischemia (CLTI), based on symptoms and tissue loss. The classification ranges are from Class 0 where no symptoms of PAD are present and the patient has no claudication or tissue loss to Class 6 where patients have extensive tissue loss, including gangrene, that extends above the transmetatarsal level (the area above the bones of the foot). A higher score on the Rutherford Classification Scale is indicative of a worse outcome.
Toe-brachial Index (TBI) Reported as Change From Baseline	30 Days	The TBI is the ratio of systolic blood pressure measured at the toe to systolic blood pressure at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
Number of Participants Free From Major Target Limb Amputation	30 Days

Trial Locations

Locations (43): UCSF Fresno
🇺🇸
Fresno, California, United States
Scripps Memorial Hospital
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La Jolla, California, United States
Cedars-Sinai Medical Center
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Los Angeles, California, United States
Stanford Hospital
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Palo Alto, California, United States
UC Davis Health
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Sacramento, California, United States
St. Helena Hospital
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Saint Helena, California, United States
MedStar Washington Hospital Center
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Washington, District of Columbia, United States
Tallahassee Memorial Hospital
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Tallahassee, Florida, United States
Piedmont Heart Institute
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Atlanta, Georgia, United States
Rush University Medical Center
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Chicago, Illinois, United States
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UCSF Fresno
🇺🇸Fresno, California, United States