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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07000097

Acronym

3DPAD-1

Enrollment

100

Registered

2025-06-02

Start date

2022-01-05

Completion date

2025-09-30

Last updated

2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease (PAD)

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.

Interventions

DEVICEPTA 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

DEVICEPTA (Standard of Care)

Preoperative planning performed based on computed tomography angiography

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 20, 2026