Actively Recruiting
Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access
Led by EndoCore Lab s.r.l. · Updated on 2026-03-25
40
Participants Needed
6
Research Sites
218 weeks
Total Duration
On this page
Sponsors
E
EndoCore Lab s.r.l.
Lead Sponsor
F
Fondazione Italiana Vascolare
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patient or legal representative understands the procedure and provides written consent before joining
- Aortic disease requiring endovascular treatment with severely calcified iliac access making the procedure difficult
- Ratio greater than 0.2 between the outer diameter of the aortic stent graft delivery system and the minimum lumen diameter
- Calcium grade 3 or 4 based on 360° coronary classification
- Lesion length greater than 20 mm, summing all calcified iliac lesions from aortic bifurcation to proximal common femoral artery
- Eligible for treatment with Shockwave M5+ IVL device
- Aortic disease indicated for endovascular treatment with or without aorto-iliac occlusive disease (Rutherford score II - VI for chronic limb ischemia)
- Able to comply with follow-up visits as scheduled
You will not qualify if you...
- Bilateral iliac artery occlusion
- Urgent condition with iliac thrombus causing acute limb ischemia
- Hemodynamically unstable at the start of the procedure
- Refusal of treatment
- Contraindications to antiplatelet therapy, anticoagulants, or thrombolytic drugs
- History of life-threatening reaction to contrast medium
- Life expectancy less than twelve months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Azienda Ospedaliero Universitaria delle Marche
Ancona, Ancona, Italy, 60126
Actively Recruiting
2
Sant'Orsola Hospital
Bologna, Emilia-Romagna, Italy, 40138
Not Yet Recruiting
3
Fondazione PTV - Policlinico Tor Vergata
Rome, Lazio, Italy, 00133
Actively Recruiting
4
Ospedale San Giovanni di Dio
Florence, Tuscany, Italy, 50143
Not Yet Recruiting
5
Ospedale Santa Maria della Misericordia di Perugia
Perugia, Umbria, Italy, 06156
Not Yet Recruiting
6
Azienda Ospedaliero-Universitaria di Padova
Padova, Veneto, Italy, 35128
Not Yet Recruiting
Research Team
D
Daniela Ramaccini, PhD, PharmD
CONTACT
S
Stefano Fazzini, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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