Status:
ACTIVE_NOT_RECRUITING
Use of Three-Dimensional Printed Models for Endovascular Planning and Follow-up in Patients Affected by Aorto-Iliac-Femoral-Popliteal Arterial Disease Undergoing Balloon Angioplasty. A Single-center, Single-blind Randomized Controlled Trial
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Parma
Conditions:
Peripheral Artery Disease (PAD)
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
Lower extremity peripheral arterial disease is a major health problem. Currently, balloon angioplasty represents the most commonly performed treatment for patients affected by vascular claudication or...
Eligibility Criteria
Inclusion
- Age between 18 and 89 years;
- Severe claudication or critical limb ischemia (Rutherford categories 3-5 \[Cronenwett and Johnston. Rutherford's Vascular Surgery 7th edition. Saunders Elsevier 2010\]) and indication already established for endovascular revascularization treatment (according to the current Italian SICVE guidelines);
- Atherosclerotic disease involving the aorto-iliac-femoro-popliteal segment;
- Signed informed consent.
Exclusion
- Age \<18 years or \>89 years;
- Preoperative CTA not available for any reason (clinical contraindication, logistical impossibility);
- Patients requiring urgent intervention (lack of time for 3D model printing);
- Atherosclerotic disease limited to tibial vessels only (absent or non-significant atherosclerosis at aorto-iliac-femoro-popliteal level);
- Patient refusal to participate in the study.
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07000097
Start Date
January 5 2022
End Date
September 30 2025
Last Update
June 2 2025
Active Locations (1)
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1
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, Italy, 43126