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

NCT ID: NCT07000097

Last Updated: 2025-06-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2025-09-30

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.

Conditions

Peripheral Artery Disease (PAD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Preoperative planning performed based on CTA (standard of care)

Group Type: ACTIVE_COMPARATOR

PTA (Standard of Care)

Intervention Type: DEVICE

Preoperative planning performed based on computed tomography angiography

Preoperative planning performed using CTA and a patient-specific, custom-made 3D-printed model

Group Type: EXPERIMENTAL

PTA planning supported by 3D-printed model

Intervention Type: DEVICE

Custom-made 3D-printed model as an additional tool to computed tomography angiography for planning Percutaneous Transluminal Angioplasty in aorto-iliac-femoral-popliteal artery disease

Interventions

PTA planning supported by 3D-printed model

Custom-made 3D-printed model as an additional tool to computed tomography angiography for planning Percutaneous Transluminal Angioplasty in aorto-iliac-femoral-popliteal artery disease

Intervention Type: DEVICE

PTA (Standard of Care)

Preoperative planning performed based on computed tomography angiography

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria di Parma

OTHER

Sponsor Role: lead

Responsible Party

Paolo Perini

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliero-Universitaria di Parma

Parma, PR, Italy

Countries

Italy

Other Identifiers

GR-2019-12369941

Identifier Type: -

Identifier Source: org_study_id