NCT05880641 Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access
| NCT ID | NCT05880641 |
| Status | Recruiting |
| Phase | — |
| Sponsor | EndoCore Lab s.r.l. |
| Condition | Aortic Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-06-26 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2023-06-26 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Stefano Fazzini, MD
PRINCIPAL INVESTIGATOR
Fondazione PTV - Policlinico Tor Vergata
Frequently Asked Questions
Who can join the NCT05880641 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05880641 currently recruiting?
Yes, NCT05880641 is actively recruiting participants. Contact the research team at d.ramaccini@endocorelab.org for enrollment information.
Where is the NCT05880641 trial being conducted?
This trial is being conducted at Ancona, Italy, Bologna, Italy, Rome, Italy, Florence, Italy and 2 additional locations.
Who is sponsoring the NCT05880641 clinical trial?
NCT05880641 is sponsored by EndoCore Lab s.r.l.. The principal investigator is Stefano Fazzini, MD at Fondazione PTV - Policlinico Tor Vergata. The trial plans to enroll 40 participants.