Aortic Diseases, Aorto-Iliac Atherosclerosis, Peripheral Arterial Disease
Conditions
Keywords
Aortic Disease, Intravascular Lithotripsy, Hostile Access
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
EndoCore Lab s.r.l.
Fondazione Italiana Vascolare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Lumen Diameter (MLD) Gain | Baseline, Day 1 | Minimum Lumen Diameter (MLD) Gain defined as the difference between MLD post-procedure and MLD pre-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of Shockwave™ M5+ IVL | Day 1 | Technical success of Shockwave™ M5+ IVL defined as the successful delivery and positioning of the aortic endograft; |
| Composite of Freedom from iliac complications | Day 1, 1 Month | Freedom from iliac complications composite (flow-limiting dissections, distal embolizations, trauma, rupture) at day 1, 30 days |
| Freedom from vessel flow-limiting dissections | Day 1, 1 Month | Freedom from vessel flow-limiting dissections at day 1 and 1 Month |
| Freedom from vessel distal embolization | Day 1, 1 Month | Freedom from vessel distal embolization at day 1 and 1 Month |
| Freedom from vessel trauma | Day 1, 1 Month | Freedom from vessel trauma at day 1 and 1 Month |
| Freedom from vessel rupture | Day 1, 1 Month | Freedom from vessel rupture at day 1 and 1 Month |
| Freedom from bailout manoeuvres | Day 1 | Freedom from bailout manoeuvres (stenting/endoconduits) at day 1 |
| Freedom from iliac secondary procedures | Day 1 | Freedom from iliac secondary procedures other than IVL at day 1 |
| Freedom from access-site adjunctive/secondary procedures; | Day 1 | Freedom from access-site adjunctive/secondary procedures |
| Primary patency of the target lesion for each iliac axis treated with IVL | 1 month, 6 months, 12 months | Primary patency of the target lesion for each iliac axis treated with IVL: defined as a lesion without a severe restenosis/occlusion and without target lesion reintervention (TLR) within 1, 6 and 12 month |
| Freedom from SAE | Day 1, 1 month | Freedom from SAE at discharge/30 days |
| All-cause mortality | 1 month, 6 months, 12 moths | All-cause mortality at 1, 6 and 12 months; |
| Freedom from Clinically-driven TLR | 1 month, 6 months, 12 months | Freedom from Clinically-driven TLR at 30 days, 6 and 12 months (any TLR for symptoms or ABI decrease \> 30%; Clinically-driven Target Lesion Revascularization (CD-TLR) defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure |
| Rutherford shift | 1 month, 6 months, 12 months | Rutherford shift from procedure at 30 days, 6 and 12 months (for AIOD subgroup) |
| Device Success | Day 1 | Device Success, defined as correct placement of the catheter and delivery of IVL (inflating balloon-delivering sonic pressure waves-deflating balloon) and recovery of the undamaged catheter; |
| Procedural Success | Day 1 | Procedural Success, defined as the presence of a residual stenosis \< 50% (without stents and/or iliac limbs) or ≤ 30% (with stents and/or iliac limbs) by completion angiogram estimation; |
| Clinical Success | Day 1, 1 month | Clinical Success, defined as procedural success without SAE before discharge |
| Freedom from procedure related complications | Day 1 | Freedom from procedure related complications |
| CASS score (exploratory endpoint) | Baseline | Calcified Access Severity Score (CASS) at baseline CASS (Calcified Access Severity Score) multifactorial severity scale, which can be referred to for the definition of iliac access hostility |
Countries
Italy
Contacts
CONTACTDaniela Ramaccini, PhD, PharmD
CONTACTStefano Fazzini, MD
PRINCIPAL_INVESTIGATORStefano Fazzini, MD
Fondazione PTV - Policlinico Tor Vergata
STUDY_CHAIRPierluigi Antignani, MD
Fondazione Italiana Vascolare (FIV)
STUDY_DIRECTORGabriele Morselli, PharmD
EndoCore Lab
Outcome results
None listed