Active — Not RecruitingNot Applicable

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

Italy100 participantsStarted 2022-01-05

Plain-language 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 critical limb ischemia. Pre-operative planning for aorto-iliac-femoral-popliteal atherosclerotic disease is a complex procedure, since an inappropriate strategy may lead to peri-operative complications. The aim of this study is to propose an innovative planning strategy for balloon angioplasty with the support of complex 3D printed models. The goal is to reduce peri-operative complications and overall costs, while improving technical success and mid-term patency of revascularizations.

Who can participate

Age range18 Years – 89 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Confirm the effectiveness of 3D-printed models for the preoperative planning of aorto-iliac-femoral-popliteal PTA

Timeframe: From treatment to the end of the post-operative period (30 days)

Trial details

NCT IDNCT07000097

SponsorAzienda Ospedaliero-Universitaria di Parma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-09