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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
Italy6 sites in 1 countryChoose a country to see its 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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