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

Not Applicable

Completed

Conditions: Peripheral Arterial Disease

Registration Number: NCT05058456

Lead Sponsor: Shockwave Medical, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

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.
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.

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.
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.
Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).
Subject already enrolled into this study.
- Angiographic Exclusion Criteria
Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries with ≤30% residual stenosis, and no serious angiographic complications (e.g. embolism).
Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism).
Target lesion includes in-stent restenosis.
Evidence of aneurysm or thrombus in target vessel.
No calcium or mild calcium in the target lesion.
Target lesion within native or synthetic vessel grafts.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Safety: Major Adverse Events (MAE)	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	Peri-Procedural	Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core lab

Secondary Outcome Measures

Name	Time	Method
Primary Patency at 12-Months	12-Months Post Procedure	* Above the knee lesions: freedom from ≥50% restenosis as determined by Duplex Ultrasound (DUS) and freedom from Clinically-Driven Target Lesion Revascularization (CD-TLR) * Below the knee lesions: freedom from both total occlusion (100% diameter stenosis by DUS) in all of the target lesions in a flow pathway, as well as a CD-TLR
MAEs at 12-months Post Procedure	12 Months Post-Procedure	Major Adverse Events (MAEs) at 12 months defined as a composite of: * Cardiovascular Death * Clinically-driven Target Lesion Revascularization * Unplanned Target Limb Amputation (Above the Ankle)
Serious Angiographic Complications	Peri-Procedural	Defined as flow-limiting dissection (≥ Grade D), perforation, distal embolization, or acute vessel closure as assessed by the angiographic core laboratory.
IVL Technical Success (Post- Dilatation)	Peri-Procedural	Defined as post-dilatation residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion, assessed by angiographic core laboratory (measured immediately following mandatory post-dilatation).
MAEs at 6-months Post Procedure	6 Months Post-Procedure	Major Adverse Events (MAEs) at 6 months defined as a composite of: * Cardiovascular Death * Clinically-driven Target Lesion Revascularization * Unplanned Target Limb Amputation (Above the Ankle)
IVL Device Success	Peri-Procedural	Defined as the ability to deliver, advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL Catheter
Technical Success (Final)	Peri-Procedural	Defined as final residual stenosis of ≤30% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core laboratory

Trial Locations

Locations (4): Sir Charles Gairdner Hospital
🇦🇺
Nedlands, Perth, Australia
Royal Perth Hospital
🇦🇺
Perth, Australia
Auckland City Hospital
🇳🇿
Auckland, New Zealand
Waikato Hospital
🇳🇿
Hamilton, New Zealand
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Perth, Australia