Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEndoCore Lab s.r.l.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Minimum Lumen Diameter (MLD) Gain
Minimum Lumen Diameter (MLD) Gain defined as the difference between MLD post-procedure and MLD pre-procedure.
Time frame
Baseline, Day 1Secondary outcomes
1
Technical success of Shockwave™ M5+ IVL
Technical success of Shockwave™ M5+ IVL defined as the successful delivery and positioning of the aortic endograft;
Time frame
Day 12
Composite of Freedom from iliac complications
Freedom from iliac complications composite (flow-limiting dissections, distal embolizations, trauma, rupture) at day 1, 30 days
Time frame
Day 1, 1 Month3
Freedom from vessel flow-limiting dissections
Freedom from vessel flow-limiting dissections at day 1 and 1 Month
Time frame
Day 1, 1 Month4
Freedom from vessel distal embolization
Freedom from vessel distal embolization at day 1 and 1 Month
Time frame
Day 1, 1 MonthSponsors and contacts
Click on the lead sponsor to view all of their trials.
EndoCore Lab s.r.l.
Lead sponsor
Fondazione Italiana Vascolare
Collaborator
Source ClinicalTrials.gov