Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System

NCT05058456 | Completed Results DMC

• 1 other identifier: CP 65324
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 4

Brief Summary

Prospective, multi-center, single-arm feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Primary Safety: Major Adverse Events (MAE)

  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 Performance: Technical Success

  Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core lab

  Peri-Procedural

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)

Single-arm

EXPERIMENTAL

Device: Shockwave Medical Mini S Peripheral IVL Catheter

Interventions

Shockwave Medical Mini S Peripheral IVL Catheter DEVICE

The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.

Single-arm

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. 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 (4)

Sir Charles Gairdner Hospital

Nedlands, Perth, Australia

Location

Royal Perth Hospital

Perth, Australia

Location

Auckland City Hospital

Auckland, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

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: Kavita Arjungi
• Organization: Shockwave Medical

karjungi@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: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: March 16, 2022
• Primary Completion: December 19, 2023
• Study Completion: December 5, 2024
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-05

Locations

NZ (2); AU (2)