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

NCT07000097 | Active Not Recruiting DMC

• 1 other identifier: GR-2019-12369941
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Preoperative planning performed based on CTA (standard of care)

ACTIVE COMPARATOR

Device: PTA (Standard of Care)

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

EXPERIMENTAL

Device: PTA planning supported by 3D-printed model

Interventions

PTA planning supported by 3D-printed model 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

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

PTA (Standard of Care) DEVICE

Preoperative planning performed based on computed tomography angiography

Preoperative planning performed based on CTA (standard of care)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria di Parma

Parma, PR, 43126, Italy

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 2, 2025
• Study Start: January 5, 2022
• Primary Completion: December 9, 2024
• Study Completion: September 30, 2025
• Last Updated: June 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)