Clinical trial NCT05007925: Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: Shockwave Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

- General Inclusion Criteria

1. Age of subject is ≥ 18.
2. Subject is able and willing to comply with all assessments in the study.
3. 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.
4. 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.
5. Estimated life expectancy \>1 year.

   * Angiographic Inclusion Criteria
6. Up to 2 below-the-knee target lesion(s) in native vessels in one or both limbs.
7. Target lesion reference vessel diameter (RVD) between 2.0 mm and 4.0 mm by investigator visual estimate.
8. Target lesion with ≥70% stenosis by investigator visual estimate.
9. Target lesion length is ≤200 mm by investigator visual estimate. Target lesion can be all or part of the 200 mm treated zone.
10. Distal reconstitution of at least one pedal vessel (\<50% stenosis) (desert foot excluded).
11. 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

1. Rutherford Category 0, 1, 2 or 6 (target limb).
2. 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) .
3. History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure.
4. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
5. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
6. Subject has known allergy to urethane, nylon, or silicone.
7. Myocardial infarction within 30 days prior to enrollment.
8. History of stroke within 60 days prior to enrollment.
9. Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy.
10. Subject is pregnant or nursing.
11. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
12. 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.
13. Covid-19 diagnosis within 90 days.
14. The planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesions during the index procedure.
15. Planned major amputation (of either leg).
16. Acute limb ischemia.
17. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).
18. Subject has an anticipated life span of less than one (1) year.
19. Subject already enrolled into this study.

    * Angiographic Exclusion Criteria
20. 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).
21. 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 ).
22. Failed PTA in target lesion during index procedure with angiographic evidence of serious angiographic complications .
23. Target lesion includes in-stent restenosis.
24. Evidence of aneurysm or thrombus in target vessel.
25. No calcium or mild calcium in the target lesion.
26. Target lesion within native or synthetic vessel grafts.
27. 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.

Primary outcomes:
measure: Procedure Success
timeFrame: At procedure
measure: Major Adverse Limb Events (MALE) + Post-Operative Death (POD)
timeFrame: 30 days
Secondary outcomes:
measure: Serious angiographic complications
timeFrame: At procedure
measure: Lesion Success
timeFrame: At procedure
measure: Primary Patency
timeFrame: 6 and 12 months
measure: Clinically Relevant Target Lesion Failure (CR-TLF)
timeFrame: 30 days, 6, 12 & 24 months
measure: Major Adverse Events (MAE)
timeFrame: 30 days
measure: VascuQoL
timeFrame: 30 days, 6, 12 & 24 months
measure: Ankle-brachial index (ABI) or toe-brachial index (TBI)
timeFrame: 30 days, 6, 12 & 24 months
measure: Rutherford Category
timeFrame: 30 days, 6, 12 & 24 months
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UCSF Fresno
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Hospital
state: California
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: Saint Helena
country: United States
facility: St. Helena Hospital
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Olney
country: United States
facility: Medstar Montgomery Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New Bedford
country: United States
facility: Southcoast Hospitals Group
state: Massachusetts
city: Bay City
country: United States
facility: McLaren Bay Heart and Vascular
state: Michigan
city: Lansing
country: United States
facility: McLaren Greater Lansing
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center/NYPH
state: New York
city: Charlotte
country: United States
facility: Charlotte Radiology
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Heart & Vascular
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Bartlesville
country: United States
facility: Ascension St Johns Heart & Vascular Center
state: Oklahoma
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Kingsport
country: United States
facility: Wellmont Cardiology Services dba CVA Heart Institute
state: Tennessee
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons
state: Texas
city: Dallas
country: United States
facility: Texas Health Presbyterian Hospital
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White - The Heart Hospital Baylor
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Health Care Systems - Seattle
state: Washington
city: Arnsberg
country: Germany
facility: Karolinen-Hospital Hüsten
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg & Bad Krozingen
city: Bad Oeynhausen
country: Germany
facility: Universitätsklinikum der Ruhr-Universitaet Bochum
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AoR
Study officials:
References: