Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access

EndoCore Lab s.r.l.40 enrolled

Overview

The study will evaluate, in a controlled setting, the efficacy and safety of the intravascular lithotripsy using Shockwave™ M5+/L6 Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices in iliac calcified access.

This study is designed as no-profit, pilot, observational, multicentric, prospective study. All eligible subjects for undergoing intervention with Shockwave™ M5+/L6 Peripheral Intravascular Lithotripsy Catheter (IVL) at sites participating in the study will be considered for enrolment and will be asked to give consent prior to participating. Subjects will be considered enrolled in the study at the time written informed consent is given to the use of their personal data. Once patients are enrolled, their demographics, medical history, disease-relevant conditions, treatment details and outcomes will be collected for up to 12 months from the procedure. The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done. The procedure with Shockwave™ M5+/L6 Peripheral Intravascular Lithotripsy Catheter (IVL) will be performed as per the current instructions for use. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days),12 months (±30 days).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Diseases Aorto-Iliac Atherosclerosis Peripheral Arterial Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years old; * Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study; * Patient presenting with aortic disease indicated for endovascular treatment considered unfeasible based on severely calcified iliac access and outer diameter of the "ideal" aortic endograft at onset of the procedure (considering the main body and/or contralateral limb in case of iliac distal landing zone); * Patients presenting a ratio \> 0.2 between outer diameter of the aortic stent graft delivery system (OD-SG) and minimum lumen diameter (MLD); decision concerning SG will be taken balancing the lower profile on the market and the better graft fit for patient's anatomy; * Patients presenting calcium grade 3 or 4 accordingly to 360° coronary classification (grade 1 = 0-90°, grade 2 = 90°-180°; grade 3 = 180°-270°; grade 4 = 270°-360°); * Patients presenting a lesion length \> 20 mm, intended as the sum of all calcified iliac lesions between two endpoints, from the aortic bifurcation up to the proximal common femoral artery (CFA); * Patients eligible for treatment with Shockwave M5+ IVL device; * Patients presenting with aortic disease indicated for endovascular treatment associated or not to aorto-iliac occlusive disease (Rutherford classification score II - VI for chronic limb ischemia); * Patients compliant with the conduct of follow-up visits according to the timelines specified in the protocol. Exclusion Criteria: * Bilateral Iliac Occlusion; * Urgent setting with presence of iliac thrombus (acute limb ischemia); * Any patient considered to be hemodynamically unstable at procedure onset; * Patients refusing treatment; * Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated; * Patients with a history of prior life-threatening contrast medium reaction; * Life expectancy of less than twelve months.

Locations (6)

Azienda Ospedaliero Universitaria delle Marche

Ancona, Ancona, Italy

RECRUITING

Sant'Orsola Hospital

Bologna, Emilia-Romagna, Italy

NOT_YET_RECRUITING

Fondazione PTV - Policlinico Tor Vergata

Rome, Lazio, Italy

Outcomes

Primary Outcomes

Minimum Lumen Diameter (MLD) Gain

Minimum Lumen Diameter (MLD) Gain defined as the difference between MLD post-procedure and MLD pre-procedure.

Time frame: Baseline, Day 1

Secondary Outcomes

Technical success of Shockwave™ M5+ IVL

Technical success of Shockwave™ M5+ IVL defined as the successful delivery and positioning of the aortic endograft;

Time frame: Day 1

Composite of Freedom from iliac complications

Freedom from iliac complications composite (flow-limiting dissections, distal embolizations, trauma, rupture) at day 1, 30 days

Time frame: Day 1, 1 Month

Freedom from vessel flow-limiting dissections

Freedom from vessel flow-limiting dissections at day 1 and 1 Month

Time frame: Day 1, 1 Month

Freedom from vessel distal embolization

Freedom from vessel distal embolization at day 1 and 1 Month

Time frame: Day 1, 1 Month

Freedom from vessel trauma

Freedom from vessel trauma at day 1 and 1 Month

Time frame: Day 1, 1 Month

Freedom from vessel rupture

Freedom from vessel rupture at day 1 and 1 Month

Time frame: Day 1, 1 Month

Freedom from bailout manoeuvres

Freedom from bailout manoeuvres (stenting/endoconduits) at day 1

Central Contacts

Daniela Ramaccini, PhD, PharmD

CONTACT

+39 3534390426 d.ramaccini@endocorelab.org

Stefano Fazzini, MD

CONTACT

+39 06 20902 833 stefano.fazzini@uniroma2.it

Data from ClinicalTrials.gov

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