FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter

NCT ID: NCT05858905

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-27
• Study Completion Date: 2025-04-21

Brief 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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JAVELIN Study Catheter

The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.

Group Type: EXPERIMENTAL

Intravascular Lithotripsy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

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.

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shockwave Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford Hospital and Clinics (SHC)

Palo Alto, California, United States

Advanced Heart and Vein Center

Thornton, Colorado, United States

HCA Florida Blake Hospital

Bradenton, Florida, United States

Tallahassee Memorial Healthcare, Inc.

Tallahassee, Florida, United States

UnityPoint Health Trinity Bettendorf Hospital

Bettendorf, Iowa, United States

Cardiovascular Medicine PC

Davenport, Iowa, United States

MedStar Montgomery Medical Center

Olney, Maryland, United States

Southcoast Hospitals Group

New Bedford, Massachusetts, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

NYU Langone Health

New York, New York, United States

Charlotte Radiology

Charlotte, North Carolina, United States

The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, United States

Ascension St. John Jane Phillips Hosptial

Bartlesville, Oklahoma, United States

Lankenau Institute for Medical Research

Bryn Mawr, Pennsylvania, United States

The Miriam Hospital

Providence, Rhode Island, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

The Heart Hospital Baylor

Plano, Texas, United States

Sentara Vascular Specialists

Norfolk, Virginia, United States

Marshfield Medical Center

Marshfield, Wisconsin, United States

Ascension Columbia St. Mary's

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CP 67398

Identifier Type: -

Identifier Source: org_study_id