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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative planning performed based on CTA (standard of care) | Active Comparator |
| |
| Preoperative planning performed using CTA and a patient-specific, custom-made 3D-printed model | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | 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) |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria di Parma | Parma | PR | 43126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42314902 | Derived | Perini P, Martini C, Massoni CB, Puntoni M, Maglietta G, Catasta A, Mersanne A, Freyrie A, Foresti R. Custom Made Three Dimensional Printed Models for Pre-operative Planning and Simulation of Endovascular Treatment of Peripheral Artery Disease (3DPAD-1): A Single Blind Randomised Controlled Trial. Eur J Vasc Endovasc Surg. 2026 Jun 18:S1078-5884(26)00604-0. doi: 10.1016/j.ejvs.2026.06.035. Online ahead of print. |
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| PTA (Standard of Care) | Device | Preoperative planning performed based on computed tomography angiography |
|
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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