SHOCK-ACCESS: Use of Shockwave M5+ IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access

Sponsor

EndoCore Lab s.r.l. (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05880641

Collaborator

Fondazione Italiana Vascolare (Other)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Diseases Aorto-Iliac Atherosclerosis Peripheral Arterial Disease

Detailed Description

This study is designed as no-profit, pilot, observational, multicentric, prospective study.

All eligible subjects for undergoing intervention with Shockwave™ M5+ 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+ 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 Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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.

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sant'Orsola Hospital	Bologna	Emilia-Romagna	Italy	40138
2	Fondazione PTV - Policlinico Tor Vergata	Rome	Lazio	Italy	00133
3	Ospedale San Giovanni di Dio	Firenze	Toscana	Italy	50143
4	Ospedale Santa Maria della Misericordia di Perugia	Perugia	Umbria	Italy	06156
5	Azienda Ospedaliero-Universitaria di Padova	Padova	Veneto	Italy	35128

Sponsors and Collaborators

EndoCore Lab s.r.l.
Fondazione Italiana Vascolare

Investigators

Principal Investigator: Stefano Fazzini, MD, Fondazione PTV - Policlinico Tor Vergata
Study Chair: Pierluigi Antignani, MD, Fondazione Italiana Vascolare (FIV)
Study Director: Gabriele Morselli, PharmD, EndoCore Lab