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 (3DPAD-1)

Azienda Ospedaliero-Universitaria di Parma

Status: Active, not recruiting

Conditions: Peripheral Artery Disease (PAD)

Treatments: Device: PTA planning supported by 3D-printed model; Device: PTA (Standard of Care)

Study type: Interventional

Funder types: Other

Identifiers

NCT07000097

GR-2019-12369941

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Preoperative planning performed based on CTA (standard of care)

Active Comparator group

Treatment:

Device: PTA (Standard of Care)

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

Experimental group

Treatment:

Device: PTA planning supported by 3D-printed model