Taking people in ItalyNo phase
Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access
Key facts
- Who runs it
- EndoCore Lab s.r.l.
- Where
- Ancona, Bologna, Florence, Padova, Perugia, and Rome, ItalySee the 6 sites
- Trial code
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 26 Jun 2023
- Expected to end
- Sept 2027
- Type of study
- Observational
- Record updated
- 25 March 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- Patients with a history of prior life-threatening contrast medium reaction
- 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
- Life expectancy of less than twelve months
Where in Italy
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyContact: Emanuele Gatta, MDTaking people
- Sant'Orsola HospitalBologna, ItalyContact: Mauro Gargiulo, Prof.Not yet recruiting
- Ospedale San Giovanni di DioFlorence, ItalyContact: Stefano Michelagnoli, MDNot yet recruiting
- Azienda Ospedaliero-Universitaria di PadovaPadova, ItalyContact: Franco Grego, Prof.Not yet recruiting
- Ospedale Santa Maria Della Misericordia Di PerugiaPerugia, ItalyContact: Massimo Lenti, MDNot yet recruiting
- Fondazione PTV Policlinico Tor VergataRome, ItalyContact: Stefano Fazzini, MDTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- No-profit, Pilot, Observational, Multicentric, Prospective Study on the Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access to Facilitate Aortic Endovascular Repair. SHOCK-ACCESS STUDY.
- Record updated
- 25 March 2026