Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System

Peripheral Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05007925
• Other study ID #: CP 65007
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: October 15, 2025

Study information

• Verified date: January 2024
• Source: Shockwave Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: October 15, 2025
• Est. primary completion date: June 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Intravascular Lithotripsy
Localized peripheral intravascular lithotripsy

Locations

Country	Name	City	State
Germany	Karolinen-Hospital Hüsten	Arnsberg
Germany	Universitäts-Herzzentrum Freiburg & Bad Krozingen	Bad Krozingen
Germany	Universitätsklinikum der Ruhr-Universitaet Bochum	Bad Oeynhausen
Germany	Universitätsklinikum Leipzig AoR	Leipzig
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Cardiothoracic and Vascular Surgeons	Austin	Texas
United States	Ascension St Johns Heart & Vascular Center	Bartlesville	Oklahoma
United States	McLaren Bay Heart and Vascular	Bay City	Michigan
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Charlotte Radiology	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Texas Health Presbyterian Hospital	Dallas	Texas
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	UCSF Fresno	Fresno	California
United States	Pinnacle Health Cardiovascular Institute	Harrisburg	Pennsylvania
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Wellmont Cardiology Services dba CVA Heart Institute	Kingsport	Tennessee
United States	Scripps Memorial Hospital	La Jolla	California
United States	McLaren Greater Lansing	Lansing	Michigan
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Southcoast Hospitals Group	New Bedford	Massachusetts
United States	Columbia University Irving Medical Center/NYPH	New York	New York
United States	Mt. Sinai Hospital	New York	New York
United States	NYU Langone Health	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Medstar Montgomery Medical Center	Olney	Maryland
United States	Stanford Hospital	Palo Alto	California
United States	Baylor Scott & White - The Heart Hospital Baylor	Plano	Texas
United States	The Miriam Hospital	Providence	Rhode Island
United States	North Carolina Heart & Vascular	Raleigh	North Carolina
United States	UC Davis Health	Sacramento	California
United States	St. Helena Hospital	Saint Helena	California
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	VA Puget Sound Health Care Systems - Seattle	Seattle	Washington
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Shockwave Medical, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Success	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 procedure
Primary	Major Adverse Limb Events (MALE) + Post-Operative Death (POD)	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	30 days
Secondary	Serious angiographic complications	Serious angiographic complications (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab	At procedure
Secondary	Lesion Success	Lesion Success defined as final residual stenosis =50% in the target lesion without significant angiographic complications as assessed by the angiographic core lab	At procedure
Secondary	Primary Patency	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)	6 and 12 months
Secondary	Clinically Relevant Target Lesion Failure (CR-TLF)	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 occlusion	30 days, 6, 12 & 24 months
Secondary	Major Adverse Events (MAE)	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	30 days
Secondary	VascuQoL	Quality of Life (QoL) assessed by VascuQoL questionnaire at 30 days, 6, 12 & 24 months, reported as change from baseline	30 days, 6, 12 & 24 months
Secondary	Ankle-brachial index (ABI) or toe-brachial index (TBI)	Ankle-brachial index (ABI) or toe-brachial index (TBI) at 30 days, 6, 12 & 24 months, reported as change from baseline	30 days, 6, 12 & 24 months
Secondary	Rutherford Category	Rutherford Category at 30 days, 6, 12 & 24 months, reported as change from baseline	30 days, 6, 12 & 24 months