FORWARD PAD IDE Study With the Shockwave Mini S IVL Catheter

Peripheral Arterial Disease Clinical Trial

— FORWARD PAD  

Official title:

Forward-Shifted Intravascular Lithotripsy (IVL) Technology in a Prospective, Multi-center, Single-arm Investigational Device Exemption (IDE) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05858905
• Other study ID #: CP 67398
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 27, 2023
• Est. completion date: April 2025

Study information

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

Clinical Trial Summary

The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: April 2025
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

General Inclusion Criteria

1. Age of subject is = 18 years.

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. Estimated life expectancy > 1 year.

5. Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s).

Angiographic Inclusion Criteria

6. One or two target lesion(s) located in a native de novo superficial femoral, popliteal or infrapopliteal artery (above the ankle joint), in one or both limbs.

7. Target lesion reference vessel diameter (RVD) between 2.0 mm and 7.0 mm by investigator visual estimate.

8. Target lesion stenosis =70% (for vessels below the knee defined as P3 to the ankle joint) or =90% (for vessels above the knee) by investigator visual estimate.

9. Target lesion length is =150 mm by investigator visual estimate. Target lesion can be all or part of the 150 mm treated zone.

10. Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is =50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.

General Exclusion Criteria

1. Rutherford Clinical Category 0, 1 and 6 (target limb).

2. History of endovascular or surgical procedure on the target limb within the last 30 days or planned within 30 days of the index procedure, with the exception of toe amputation. Note: inflow treatment of non-target lesions is allowed providing successful treatment.

3. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.

4. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.

5. Subject has known allergy to urethane, nylon, or silicone.

6. Myocardial infarction within 60 days prior to enrollment.

7. History of stroke within 60 days prior to enrollment.

8. Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy.

9. Subject is pregnant or nursing.

10. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.

11. 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.

12. Covid-19 diagnosis within 30 days.

13. Planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesion(s) during the index procedure.

14. Planned major amputation of target limb.

15. Acute limb ischemia.

16. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).

17. Subject already enrolled into this study.

Angiographic Exclusion Criteria

18. Failure to successfully treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries, defined as =30% residual stenosis with no serious angiographic complications (e.g. embolism).

19. Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to treatment of target lesion(s). Successful treatment is defined as obtaining =50% residual stenosis with no serious angiographic complications (e.g., embolism).

20. Target lesion includes in-stent restenosis.

21. Evidence of aneurysm or thrombus in target vessel.

22. No calcium or mild calcium in the target lesion.

23. Target lesion within native or synthetic vessel grafts.

24. 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 Vascular Diseases

Intervention

Device:
• Intravascular Lithotripsy
The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.

Locations

Country	Name	City	State
United States	Ascension St. John Jane Phillips Hosptial	Bartlesville	Oklahoma
United States	UnityPoint Health Trinity Bettendorf Hospital	Bettendorf	Iowa
United States	HCA Florida Blake Hospital	Bradenton	Florida
United States	Lankenau Institute for Medical Research	Bryn Mawr	Pennsylvania
United States	Charlotte Radiology	Charlotte	North Carolina
United States	The Lindner Research Center at The Christ Hospital	Cincinnati	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Cardiovascular Medicine PC	Davenport	Iowa
United States	Marshfield Medical Center	Marshfield	Wisconsin
United States	Ascension Columbia St. Mary's	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Southcoast Hospitals Group	New Bedford	Massachusetts
United States	NYU Langone Health	New York	New York
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	MedStar Montgomery Medical Center	Olney	Maryland
United States	The Heart Hospital Baylor	Plano	Texas
United States	The Miriam Hospital	Providence	Rhode Island
United States	Tallahassee Memorial Healthcare, Inc.	Tallahassee	Florida
United States	Advanced Heart and Vein Center	Thornton	Colorado
United States	North Mississippi Medical Center	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Shockwave Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint - Major Adverse Events (MAE) at 30 days	Major Adverse Events (MAE) at 30 days defined as a composite of: Cardiovascular death; Clinically-driven target lesion revascularization (CD-TLR); Unplanned target limb major amputation (above the ankle)	30 Days
Primary	Primary Effectiveness Endpoint - Technical Success	Technical Success defined as final residual stenosis =50% without flow-limiting dissection (= Grade D) of the target lesion as assessed by angiographic core lab.	Peri-Procedural