Clinical trial NCT05880641: Use of Shockwave M5+ IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Diseases
Aorto-Iliac Atherosclerosis
Peripheral Arterial Disease
Keywords: Aortic Disease
Intravascular Lithotripsy
Hostile Access
Lead sponsor: EndoCore Lab s.r.l.
Sponsor class: OTHER
Collaborators: name: Fondazione Italiana Vascolare
First posted: 2023-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Minimum Lumen Diameter (MLD) Gain
timeFrame: Baseline, Day 1
Secondary outcomes:
measure: Technical success of Shockwave™ M5+ IVL
timeFrame: Day 1
measure: Composite of Freedom from iliac complications
timeFrame: Day 1, 1 Month
measure: Freedom from vessel flow-limiting dissections
timeFrame: Day 1, 1 Month
measure: Freedom from vessel distal embolization
timeFrame: Day 1, 1 Month
measure: Freedom from vessel trauma
timeFrame: Day 1, 1 Month
measure: Freedom from vessel rupture
timeFrame: Day 1, 1 Month
measure: Freedom from bailout manoeuvres
timeFrame: Day 1
measure: Freedom from iliac secondary procedures
timeFrame: Day 1
measure: Freedom from access-site adjunctive/secondary procedures;
timeFrame: Day 1
measure: Primary patency of the target lesion for each iliac axis treated with IVL
timeFrame: 1 month, 6 months, 12 months
measure: Freedom from SAE
timeFrame: Day 1, 1 month
measure: All-cause mortality
timeFrame: 1 month, 6 months, 12 moths
measure: Freedom from Clinically-driven TLR
timeFrame: 1 month, 6 months, 12 months
measure: Rutherford shift
timeFrame: 1 month, 6 months, 12 months
measure: Device Success
timeFrame: Day 1
measure: Procedural Success
timeFrame: Day 1
measure: Clinical Success
timeFrame: Day 1, 1 month
measure: Freedom from procedure related complications
timeFrame: Day 1
measure: CASS score (exploratory endpoint)
timeFrame: Baseline
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Sant'Orsola Hospital
state: Emilia-Romagna
city: Rome
country: Italy
facility: Fondazione PTV - Policlinico Tor Vergata
state: Lazio
city: Firenze
country: Italy
facility: Ospedale San Giovanni di Dio
state: Toscana
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia di Perugia
state: Umbria
city: Padova
country: Italy
facility: Azienda Ospedaliero-Universitaria di Padova
state: Veneto
Study officials:
affiliation: Fondazione PTV - Policlinico Tor Vergata
name: Stefano Fazzini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Italiana Vascolare (FIV)
name: Pierluigi Antignani, MD
role: STUDY_CHAIR
affiliation: EndoCore Lab
name: Gabriele Morselli, PharmD
role: STUDY_DIRECTOR
References: