Prospective, Multi-center, Single-arm Feasibility Study of the Shockwave Medical Mini S Peripheral Intravascular Lithotripsy (IVL) System

Shockwave Medical, Inc.4 sites in 2 countries35 target enrollmentMarch 16, 2022

ConditionsPeripheral Arterial Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Shockwave Medical, Inc.
Enrollment: 35
Locations: 4
Primary Endpoint: Primary Safety: Major Adverse Events (MAE)
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 16, 2022

End Date

December 5, 2024

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shockwave Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•General Inclusion Criteria
•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).
•Angiographic Inclusion Criteria
•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.

Exclusion Criteria

•General Exclusion Criteria
•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.

Outcomes

Primary Outcomes

Primary Safety: Major Adverse Events (MAE)

Time Frame: 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)

Primary Performance: Technical Success

Time Frame: Peri-Procedural

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