Clinical trial NCT07000097: 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
Official title: 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: Applicability, Effectiveness in Technical Success and on Mid-Term Outcomes, Cost-Analysis, and Exploration of New Technologies. A Single-center, Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease (PAD)
Lead sponsor: Azienda Ospedaliero-Universitaria di Parma
Sponsor class: OTHER
First posted: 2025-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Determine the usefulness of 3D-printed models in the mid-term and during follow-up after PTA
timeFrame: From 1-month follow-up to 18-month follow-up
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
state: PR
Study officials:
References: