Peripheral Arterial Disease Clinical Trial
— SHOCK-ACCESSOfficial title:
No-profit, Pilot, Observational, Multicentric, Prospective Study on the Use of Shockwave M5+ IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access to Facilitate Aortic Endovascular Repair. SHOCK-ACCESS STUDY.
NCT number | NCT05880641 |
Other study ID # | IVL 022022 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 26, 2023 |
Est. completion date | June 2025 |
The study will evaluate, in a controlled setting, the efficacy and safety of the intravascular lithotripsy using Shockwave™ M5+ Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices in iliac calcified access.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Sant'Orsola Hospital | Bologna | Emilia-Romagna |
Italy | Ospedale San Giovanni di Dio | Firenze | Toscana |
Italy | Azienda Ospedaliero-Universitaria di Padova | Padova | Veneto |
Italy | Ospedale Santa Maria della Misericordia di Perugia | Perugia | Umbria |
Italy | Fondazione PTV - Policlinico Tor Vergata | Rome | Lazio |
Lead Sponsor | Collaborator |
---|---|
EndoCore Lab s.r.l. | Fondazione Italiana Vascolare |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Composite of Freedom from iliac complications | Freedom from iliac complications composite (flow-limiting dissections, distal embolizations, trauma, rupture) at day 1, 30 days | Day 1, 1 Month | |
Secondary | Freedom from vessel flow-limiting dissections | Freedom from vessel flow-limiting dissections at day 1 and 1 Month | Day 1, 1 Month | |
Secondary | Freedom from vessel distal embolization | Freedom from vessel distal embolization at day 1 and 1 Month | Day 1, 1 Month | |
Secondary | Freedom from vessel trauma | Freedom from vessel trauma at day 1 and 1 Month | Day 1, 1 Month | |
Secondary | Freedom from vessel rupture | Freedom from vessel rupture at day 1 and 1 Month | Day 1, 1 Month | |
Secondary | Freedom from bailout manoeuvres | Freedom from bailout manoeuvres (stenting/endoconduits) at day 1 | Day 1 | |
Secondary | Freedom from iliac secondary procedures | Freedom from iliac secondary procedures other than IVL at day 1 | Day 1 | |
Secondary | Freedom from access-site adjunctive/secondary procedures; | Freedom from access-site adjunctive/secondary procedures | Day 1 | |
Secondary | 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 | |
Secondary | Freedom from SAE | Freedom from SAE at discharge/30 days | Day 1, 1 month | |
Secondary | All-cause mortality | All-cause mortality at 1, 6 and 12 months; | 1 month, 6 months, 12 moths | |
Secondary | 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 | |
Secondary | Rutherford shift | Rutherford shift from procedure at 30 days, 6 and 12 months (for AIOD subgroup) | 1 month, 6 months, 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Clinical Success | Clinical Success, defined as procedural success without SAE before discharge | Day 1, 1 month | |
Secondary | Freedom from procedure related complications | Freedom from procedure related complications | Day 1 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
Recruiting |
NCT03506633 -
Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
|
N/A | |
Active, not recruiting |
NCT03506646 -
Dietary Nitrate Supplementation and Thermoregulation
|
N/A | |
Active, not recruiting |
NCT04677725 -
NEtwork to Control ATherothrombosis (NEAT Registry)
|
||
Recruiting |
NCT05961943 -
RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
|
N/A | |
Recruiting |
NCT06047002 -
Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
|
||
Completed |
NCT03185052 -
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
|
N/A | |
Recruiting |
NCT05992896 -
A Study of Loco-Regional Liposomal Bupivacaine Injection
|
Phase 4 | |
Completed |
NCT04635501 -
AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial
|
N/A | |
Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
Withdrawn |
NCT03994185 -
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
|
N/A | |
Withdrawn |
NCT03538392 -
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
|
||
Recruiting |
NCT02915796 -
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
|
Phase 1 | |
Active, not recruiting |
NCT02900924 -
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
|
||
Completed |
NCT02901847 -
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
|
N/A | |
Not yet recruiting |
NCT02455726 -
Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
|
N/A | |
Not yet recruiting |
NCT02387450 -
Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
|
Phase 2/Phase 3 | |
Withdrawn |
NCT02126540 -
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
|
N/A | |
Completed |
NCT02022423 -
Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease
|
N/A |