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| Name | Class |
|---|---|
| Fondazione Italiana Vascolare | OTHER |
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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).
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| Measure | Description | Time Frame |
|---|---|---|
| Minimum Lumen Diameter (MLD) Gain | Minimum Lumen Diameter (MLD) Gain defined as the difference between MLD post-procedure and MLD pre-procedure. | Baseline, Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success of Shockwave™ M5+ IVL | Technical success of Shockwave™ M5+ IVL defined as the successful delivery and positioning of the aortic endograft; | Day 1 |
| Composite of Freedom from iliac complications |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with aortic diseases (abdominal, thoracic or thoraco-abdominal, aneurysms, dissections, PAU, IMH) with hostile iliac access (calcified and narrowed) associated or not to aorto-iliac occlusive disease (AIOD).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Ramaccini, PhD, PharmD | Contact | +39 3534390426 | d.ramaccini@endocorelab.org | |
| Stefano Fazzini, MD | Contact | +39 06 20902 833 | stefano.fazzini@uniroma2.it |
| Name | Affiliation | Role |
|---|---|---|
| Stefano Fazzini, MD | Fondazione PTV - Policlinico Tor Vergata | Principal Investigator |
| Pierluigi Antignani, MD | Fondazione Italiana Vascolare (FIV) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria delle Marche | Recruiting | Ancona | Ancona | 60126 | Italy |
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| ID | Term |
|---|---|
| D001018 | Aortic Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
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Freedom from iliac complications composite (flow-limiting dissections, distal embolizations, trauma, rupture) at day 1, 30 days
| Day 1, 1 Month |
| Freedom from vessel flow-limiting dissections | Freedom from vessel flow-limiting dissections at day 1 and 1 Month | Day 1, 1 Month |
| Freedom from vessel distal embolization | Freedom from vessel distal embolization at day 1 and 1 Month | Day 1, 1 Month |
| Freedom from vessel trauma | Freedom from vessel trauma at day 1 and 1 Month | Day 1, 1 Month |
| Freedom from vessel rupture | Freedom from vessel rupture at day 1 and 1 Month | Day 1, 1 Month |
| Freedom from bailout manoeuvres | Freedom from bailout manoeuvres (stenting/endoconduits) at day 1 | Day 1 |
| Freedom from iliac secondary procedures | Freedom from iliac secondary procedures other than IVL at day 1 | Day 1 |
| Freedom from access-site adjunctive/secondary procedures; | Freedom from access-site adjunctive/secondary procedures | Day 1 |
| Primary patency of the target lesion for each iliac axis treated with IVL | 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 | 1 month, 6 months, 12 months |
| Freedom from SAE | Freedom from SAE at discharge/30 days | Day 1, 1 month |
| All-cause mortality | All-cause mortality at 1, 6 and 12 months; | 1 month, 6 months, 12 moths |
| Freedom from Clinically-driven TLR | 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 | 1 month, 6 months, 12 months |
| Rutherford shift | Rutherford shift from procedure at 30 days, 6 and 12 months (for AIOD subgroup) | 1 month, 6 months, 12 months |
| Device Success | 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; | Day 1 |
| Procedural Success | 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; | Day 1 |
| Clinical Success | Clinical Success, defined as procedural success without SAE before discharge | Day 1, 1 month |
| Freedom from procedure related complications | Freedom from procedure related complications | Day 1 |
| CASS score (exploratory endpoint) | 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 | Baseline |
| Gabriele Morselli, PharmD |
| EndoCore Lab |
| Study Director |
| Sant'Orsola Hospital | Not yet recruiting | Bologna | Emilia-Romagna | 40138 | Italy |
|
| Fondazione PTV - Policlinico Tor Vergata | Recruiting | Rome | Lazio | 00133 | Italy |
|
| Ospedale San Giovanni di Dio | Not yet recruiting | Florence | Tuscany | 50143 | Italy |
|
| Ospedale Santa Maria della Misericordia di Perugia | Not yet recruiting | Perugia | Umbria | 06156 | Italy |
|
| Azienda Ospedaliero-Universitaria di Padova | Not yet recruiting | Padova | Veneto | 35128 | Italy |
|
| D001157 |
| Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |