Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07000097
NA

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

Sponsor: Azienda Ospedaliero-Universitaria di Parma

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-01-05

Completion Date

2025-09-30

Last Updated

2025-06-02

Healthy Volunteers

No

Interventions

DEVICE

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

DEVICE

PTA (Standard of Care)

Preoperative planning performed based on computed tomography angiography

Locations (1)

Azienda Ospedaliero-Universitaria di Parma

Parma, PR, Italy