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

Peripheral Arterial Disease Clinical Trial

— SHOCK-ACCESS  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880641
• Other study ID #: IVL 022022
• Status: Recruiting
• Start date: June 26, 2023
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: EndoCore Lab s.r.l.
• Contact: Gabriele Morselli, PharmD
• Phone: +39 3499105666
• Email: g.morselli[@]endocorelab.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Aortic Diseases
• Aorto-Iliac Atherosclerosis
• Atherosclerosis
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
EndoCore Lab s.r.l.	Fondazione Italiana Vascolare

Country where clinical trial is conducted

Italy, 

Outcome

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