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

Not Applicable

Active, not recruiting

• Conditions: Peripheral Artery Disease (PAD)

• Registration Number: NCT07000097
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-05
• Primary Completion: 2024-12-09
• Status Verified: 2025-05
• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-05-30
• Last Update Submitted: 2025-05-30
• Study First Posted: 2025-06-02
• Last Update Posted: 2025-06-02
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Confirm the effectiveness of 3D-printed models for the preoperative planning of aorto-iliac-femoral-popliteal PTA	From treatment to the end of the post-operative period (30 days)

Secondary Outcome Measures

Name	Time	Method
Determine the usefulness of 3D-printed models in the mid-term and during follow-up after PTA	From 1-month follow-up to 18-month follow-up

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria di Parma; 🇮🇹 Parma, PR, Italy