Trans-femoral TAVI With Calcified Ilio-femoral ArteriesTRAFIC-PTANCT05873842
TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
An observational study of Trans-femoral TAVI With Calcified Ilio-femoral Arteries, run by Rede Optimus Hospitalar SA at 5 sites in Italy.
Trial summary
To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trans-femoral TAVI With Calcified Ilio-femoral Arteries
- What is being tested?
- Trans-femoral TAVI
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 5 sitesItaly
- Study dates
- 22 Jul 2024to 1 Nov 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with calcified ilio-femoral arteries eligible for trans-femoral TAVI
Who may be able to join
- Age > 18 years
- Written informed consent
- Diagnosis of symptomatic severe aortic stenosis
- Patient undergoing TAVI according to local institutional protocol and following Heart Team discussion.
- High-quality Contrast-enhanced ECG gated computed tomography (CT) scan of the heart, aorta and low-limb arteries
- Calcific severe PAD raising concerns within the Heart Team and judged as "arguable" for TF approach following angiography or CT-scan evaluation (hostile femoral access), with a RefD>/=5 mm and a MLD>/=3 mm.
- Hostility score >/= 23 in at least one segment of the axis under evaluation.
Who cannot join
- Life expectancy < 1 year
- Subject has active infection requiring antibiotic therapy.
- STS score ≥8%
- Leriche syndrome or other forms of total occlusion of the aorta or both iliac axes.
- Planned target limb major amputation (above the ankle).
- History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure.
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- Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
- Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
- Subject has known allergy to urethane, nylon, or silicone.
- Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
- Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
- The use of specialty balloons, re-entry or atherectomy devices
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 4 recruiting
- Recruiting
AOU Cardiology Ancona
Ancona
Tommaso Piva, PhD, +39 071 596 5165, tommaso.piva@ospedaliriuniti.marche.it
- Recruiting
AULLS3 Cardiology Mestre
Mestre
Marco Barbierato, PhD, marco.barbierato@aulss3.veneto.it
- Active, not recruiting
AULSS2 Cardiology Treviso
Treviso
- Recruiting
AOUI Cardiology Verona
Verona
Flavio Ribichini, PhD, +3945 8122320, flavio.ribichini@univr.it
- Recruiting
AULLS8 Cardiology Vicenza
Vicenza
Francseco Caprioglio, PhD, +39 444753214, francesco.caprioglio@aulss8.veneto.it
About this study
To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.
Read the detailed description
Trans-femoral (TF) access has been identified as the best vascular approach for trans-catheter aortic valve implantation (TAVI) in the most recent European Guidelines for the treatment of valvular heart disease. Nevertheless, the TF approach is not possible in a substantial number of TAVI candidates, mainly due to the presence of important peripheral arterial disease (PAD) that is perceived as a contraindication. The presence of PAD limiting TF-TAVI feasibility has always remained a challenging scenario. The concept of preparing TF access through balloon dilatation in case of PAD had been developed and, in this context, percutaneous transluminal angioplasty (PTA) with plain-balloon has been investigated, although available literature is scarce. Intra-vascular lithotripsy (IVL) was proved effective and safe to treat calcified peripheral arteries and such new technology bares the potential for being applied in TF TAVI in patients with concomitant PAD. The rationale is that the Shockwave IVL balloon inflated at low pressure modifies the vessel rigidity with creation of multiple longitudinal and transversal cracks in the calcium present within the vessel wall. Thus, the improved vessel compliance facilitates the successful passage of the valve delivery system resulting in higher rates of procedural success and lower risk for crossover to surgery, vessel injury and major complications.
- Being tested
- Trans-femoral TAVI
- Keywords
- TAVI, Calcification, Ilio-femoral arteries
- Medical subject headings
- Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-femoral TAVIDevice
Trans-femoral TAVI (Trans-catheter Aortic Valve Implantation) with calcified ilio-femoral arteries via PTA (Percutaneous transluminal angioplasty ) or IVL (Intra-vascular Lithotripsy)
| Study group | Role | What they receive |
|---|---|---|
| PTA-assisted group | Not described Receives: Device: Trans-femoral TAVI | |
| IVL-assisted group | Not described Receives: Device: Trans-femoral TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and safety on the trans-femoral (TF) approach
Comparison of feasibility and safety on the TF approach as the composite of:
- Valve implant unsuccess due to difficulties in advancing through the ilio-femoral vascular axe
- Absence of cross over from PTA to IVL or vice-versa
- Absence of severe vascular and bleeding complications at discharge and at 1 month follow up visit, as defined by VARC-3
Measured: Index procedure - 1 Month
Secondary outcomes (9)
MAEs
30-day composite occurrence of major clinical events: all-cause death, myocardial infarction and stroke
Measured: Within 30 days after index procedure
Vascular and bleeding complications
30-day occurrence of vascular and bleeding complications according to the VARC-3 definition
Measured: Within 30 days after index procedure
Device-related vascular complication
Any device-related vascular complication
Measured: Discharge, 1-months, 6-months
Residual stenosis, Degree of dissection, Final Flow
Angiographic analysis from DSA
Measured: Index procedure
Procedural time duration, amount of contrast media and radiation dose.
Procedural analysis
Measured: Index procedure
Centralized analysis of the angiographic parameters
Centralized analysis of the angiographic parameters
Measured: Index procedure
Stent Implantation
Need for stent implantation on the procedural vascular access axe.
Measured: Index procedure
Functional capacity of the inferior limbs
Functional capacity of the inferior limbs at 6 months.
Measured: 6-months
Patency at the distal level of the vascular access site
Ultrasound defined patency at the distal level of the vascular access site after 6 months.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start22 Jul 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trans-femoral TAVI With Calcified Ilio-femoral ArteriesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rede Optimus Hospitalar SA
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Flavio Ribichini, MD, PhD, Study director, AOUI, Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873842
- Sponsor's protocol ID
- RO-230301
- Acronym
- TRAFIC-PTA
- Status last verified
- May 2025
- First submitted
- 15 May 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
- ClinicalTrials.gov ID
- NCT05873842
- Acronym / sponsor ID
- TRAFIC-PTA / RO-230301
- Keywords
- TAVI, Calcification, Ilio-femoral arteries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rede Optimus Hospitalar SAResearch network
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 24 May 2023 (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.
To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.
Detailed description
Trans-femoral (TF) access has been identified as the best vascular approach for trans-catheter aortic valve implantation (TAVI) in the most recent European Guidelines for the treatment of valvular heart disease. Nevertheless, the TF approach is not possible in a substantial number of TAVI candidates, mainly due to the presence of important peripheral arterial disease (PAD) that is perceived as a contraindication. The presence of PAD limiting TF-TAVI feasibility has always remained a challenging scenario. The concept of preparing TF access through balloon dilatation in case of PAD had been developed and, in this context, percutaneous transluminal angioplasty (PTA) with plain-balloon has been investigated, although available literature is scarce. Intra-vascular lithotripsy (IVL) was proved effective and safe to treat calcified peripheral arteries and such new technology bares the potential for being applied in TF TAVI in patients with concomitant PAD. The rationale is that the Shockwave IVL balloon inflated at low pressure modifies the vessel rigidity with creation of multiple longitudinal and transversal cracks in the calcium present within the vessel wall. Thus, the improved vessel compliance facilitates the successful passage of the valve delivery system resulting in higher rates of procedural success and lower risk for crossover to surgery, vessel injury and major complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTA-assisted group | – | Device: Trans-femoral TAVI |
| IVL-assisted group | – | Device: Trans-femoral TAVI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with calcified ilio-femoral arteries eligible for trans-femoral TAVI
Key inclusion criteria (7 listed)
- Age > 18 years
- Written informed consent
- Diagnosis of symptomatic severe aortic stenosis
- Patient undergoing TAVI according to local institutional protocol and following Heart Team discussion.
- High-quality Contrast-enhanced ECG gated computed tomography (CT) scan of the heart, aorta and low-limb arteries
Key exclusion criteria (12 listed)
- Life expectancy < 1 year
- Subject has active infection requiring antibiotic therapy.
- STS score ≥8%
- Leriche syndrome or other forms of total occlusion of the aorta or both iliac axes.
- Planned target limb major amputation (above the ankle).
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 |
|---|---|---|
| Trans-femoral TAVITrans-femoral TAVI (Trans-catheter Aortic Valve Implantation) with calcified ilio-femoral arteries via PTA (Percutaneous transluminal angioplasty ) or IVL (Intra-vascular Lithotripsy) | Device | IVL-assisted group, PTA-assisted group |
Primary outcome
Feasibility and safety on the trans-femoral (TF) approach
Time frame: Index procedure - 1 Month
Comparison of feasibility and safety on the TF approach as the composite of: * Valve implant unsuccess due to difficulties in advancing through the ilio-femoral vascular axe * Absence of cross over from PTA to IVL or vice-versa * Absence of severe vascular and bleeding complications at discharge and at 1 month follow up visit, as defined by VARC-3
9 secondary outcomes
MAEs
Time frame: Within 30 days after index procedure
Vascular and bleeding complications
Time frame: Within 30 days after index procedure
Device-related vascular complication
Time frame: Discharge, 1-months, 6-months
Residual stenosis, Degree of dissection, Final Flow
Time frame: Index procedure
Procedural time duration, amount of contrast media and radiation dose.
Time frame: Index procedure
Centralized analysis of the angiographic parameters
Time frame: Index procedure
Stent Implantation
Time frame: Index procedure
Functional capacity of the inferior limbs
Time frame: 6-months
Patency at the distal level of the vascular access site
Time frame: 6-months
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 16 May 2025.
- Individual participant dataSharing planned: No
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.
Flavio Ribichini, MD, PhD study director
AOUI, Verona
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trans-femoral TAVI With Calcified Ilio-femoral Arteries, run by Rede Optimus Hospitalar SA at 5 sites 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact Azinwi Phina Muna, phd (+49 157 80 58 5869, trafic@redeoptimus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and safety on the trans-femoral (TF) approach (time frame: Index procedure - 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.