Peripheral Artery Disease (PAD)3DPAD-1NCT07000097
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
A study testing PTA planning supported by 3D-printed model in people with Peripheral Artery Disease (PAD), run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Peripheral Artery Disease (PAD)
- What is being tested?
- PTA planning supported by 3D-printed model
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jan 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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)
- Being tested
- PTA planning supported by 3D-printed model, PTA (Standard of Care)
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTA planning supported by 3D-printed modelDevice
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
PTA (Standard of Care)Device
Preoperative planning performed based on computed tomography angiography
| Study group | Role | What they receive |
|---|---|---|
| Preoperative planning performed based on CTA (standard of care) | Active comparator | Not described Receives: Device: PTA (Standard of Care) |
| Preoperative planning performed using CTA and a patient-specific, custom-made 3D-printed model | Experimental | Not described Receives: Device: PTA planning supported by 3D-printed model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm the effectiveness of 3D-printed models for the preoperative planning of aorto-iliac-femoral-popliteal PTA
Measured: 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
Measured: From 1-month follow-up to 18-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start5 Jan 2022
- Primary completion9 Dec 2024
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery Disease (PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Perini, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000097
- Sponsor's protocol ID
- GR-2019-12369941
- Acronym
- 3DPAD-1
- Status last verified
- May 2025
- First submitted
- 23 May 2025
- Last updated
- 2 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42314902
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07000097
- Acronym / sponsor ID
- 3DPAD-1 / GR-2019-12369941
- Conditions
- Peripheral Artery Disease (PAD)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 2 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTA planning supported by 3D-printed modelCustom-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 | Preoperative planning performed using CTA and a patient-specific, custom-made 3D-printed model |
| PTA (Standard of Care)Preoperative planning performed based on computed tomography angiography | Device | Preoperative planning performed based on CTA (standard of care) |
Primary outcome
Confirm the effectiveness of 3D-printed models for the preoperative planning of aorto-iliac-femoral-popliteal PTA
Time frame: From treatment to the end of the post-operative period (30 days)
1 secondary outcome
Determine the usefulness of 3D-printed models in the mid-term and during follow-up after PTA
Time frame: From 1-month follow-up to 18-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2025.
- Derived from this study: PubMed 42314902Perini 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.
- Individual participant dataSharing planned: No
Related trials for Peripheral Artery Disease (PAD)
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTA planning supported by 3D-printed model in people with Peripheral Artery Disease (PAD), run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm the effectiveness of 3D-printed models for the preoperative planning of aorto-iliac-femoral-popliteal PTA (time frame: From treatment to the end of the post-operative period (30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07000097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2025.