FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter

NCT05858905 | Completed Results DMC FDA Device

• 1 other identifier: CP 67398
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 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

Keywords

Intravascular Lithotripsy

Outcome Measures

Primary Outcomes (2)

• 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 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, immediately after all therapy of the target lesion was completed.

Secondary Outcomes (7)

• Serious Angiographic Complications

  Peri-Procedural

• IVL Technical Success (Post- Dilatation)

  Peri-Procedural

• IVL Device Success

  Peri-Procedural

• Technical Success (Final)

  Peri-Procedural

• MAEs at 6-months Post Procedure

  6 Months Post-Procedure

Study Arms (1)

JAVELIN Study Catheter

EXPERIMENTAL

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.

Device: Intravascular Lithotripsy

Interventions

Intravascular Lithotripsy 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.

JAVELIN Study Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of subject is ≥ 18 years.
• 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.
• Estimated life expectancy \> 1 year.
• Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s).
• 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.
• Target lesion reference vessel diameter (RVD) between 2.0 mm and 7.0 mm by investigator visual estimate.
• 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.
• Target lesion length is ≤150 mm by investigator visual estimate. Target lesion can be all or part of the 150 mm treated zone.
• 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.

You may not qualify if:

• Rutherford Clinical Category 0, 1 and 6 (target limb).
• 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.
• 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 60 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 30 days.
• Planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesion(s) during the index procedure.
• Planned major amputation of target limb.
• Acute limb ischemia.

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (21)

Stanford Hospital and Clinics (SHC)

Palo Alto, California, 94304, United States

Location

Advanced Heart and Vein Center

Thornton, Colorado, 80023, United States

Location

HCA Florida Blake Hospital

Bradenton, Florida, 34209, United States

Location

Tallahassee Memorial Healthcare, Inc.

Tallahassee, Florida, 32308, United States

Location

UnityPoint Health Trinity Bettendorf Hospital

Bettendorf, Iowa, 52722, United States

Location

Cardiovascular Medicine PC

Davenport, Iowa, 52803, United States

Location

MedStar Montgomery Medical Center

Olney, Maryland, 20832, United States

Location

Southcoast Hospitals Group

New Bedford, Massachusetts, 02740, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Charlotte Radiology

Charlotte, North Carolina, 28202, United States

Location

The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Ascension St. John Jane Phillips Hosptial

Bartlesville, Oklahoma, 74006, United States

Location

Lankenau Institute for Medical Research

Bryn Mawr, Pennsylvania, 19096, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The Heart Hospital Baylor

Plano, Texas, 75093, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

Marshfield Medical Center

Marshfield, Wisconsin, 54449, United States

Location

Ascension Columbia St. Mary's

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Josh Popp
• Organization: Shockwave Medical

jpopp@shockwavemedical.com

1-510-279-4262

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: June 27, 2023
• Primary Completion: April 5, 2024
• Study Completion: April 21, 2025
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Locations

US (21)