TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI (TRAFIC-PTA)

To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.

Study Overview

• Status: Recruiting
• Conditions: Trans-femoral TAVI With Calcified Ilio-femoral Arteries
• Intervention / Treatment: Device: Trans-femoral TAVI

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Azinwi Phina Muna, phd; Phone Number: +49 157 80 58 5869; Email: trafic@redeoptimus.com
• Study Contact Backup: Name: Cristian Di Biase, Phd; Phone Number: +49 176 89982768; Email: Cristian.dibiase@redeoptimus.com

Study Locations

• Italy
  • Ancona, Italy
    • Recruiting
    • AOU Cardiology Ancona
    • Contact: Tommaso Piva, PhD; Phone Number: +39 071 596 5165; Email: tommaso.piva@ospedaliriuniti.marche.it
  • Mestre, Italy
    • Recruiting
    • AULLS3 Cardiology Mestre
    • Contact: Marco Barbierato, PhD; Email: marco.barbierato@aulss3.veneto.it
  • Treviso, Italy
    • Active, not recruiting
    • AULSS2 Cardiology Treviso
  • Verona, Italy
    • Recruiting
    • AOUI Cardiology Verona
    • Contact: Flavio Ribichini, PhD; Phone Number: +3945 8122320; Email: flavio.ribichini@univr.it
  • Vicenza, Italy
    • Recruiting
    • AULLS8 Cardiology Vicenza
    • Contact: Francseco Caprioglio, PhD; Phone Number: +39 444753214; Email: francesco.caprioglio@aulss8.veneto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with calcified ilio-femoral arteries eligible for trans-femoral TAVI

Description

Inclusion Criteria:

1. Age > 18 years
2. Written informed consent
3. Diagnosis of symptomatic severe aortic stenosis
4. Patient undergoing TAVI according to local institutional protocol and following Heart Team discussion.
5. High-quality Contrast-enhanced ECG gated computed tomography (CT) scan of the heart, aorta and low-limb arteries
6. 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.
7. Hostility score >/= 23 in at least one segment of the axis under evaluation.

Exclusion Criteria:

1. Life expectancy < 1 year
2. Subject has active infection requiring antibiotic therapy.
3. STS score ≥8%
4. Leriche syndrome or other forms of total occlusion of the aorta or both iliac axes.
5. Planned target limb major amputation (above the ankle).
6. 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.
7. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
8. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
9. Subject has known allergy to urethane, nylon, or silicone.
10. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
11. 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.
12. The use of specialty balloons, re-entry or atherectomy devices

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PTA-assisted group	Device: Trans-femoral TAVI; Trans-femoral TAVI (Trans-catheter Aortic Valve Implantation) with calcified ilio-femoral arteries via PTA (Percutaneous transluminal angioplasty ) or IVL (Intra-vascular Lithotripsy)
IVL-assisted group	Device: Trans-femoral TAVI; Trans-femoral TAVI (Trans-catheter Aortic Valve Implantation) with calcified ilio-femoral arteries via PTA (Percutaneous transluminal angioplasty ) or IVL (Intra-vascular Lithotripsy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Index procedure - 1 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAEs	30-day composite occurrence of major clinical events: all-cause death, myocardial infarction and stroke	Within 30 days after index procedure
Vascular and bleeding complications	30-day occurrence of vascular and bleeding complications according to the VARC-3 definition	Within 30 days after index procedure
Device-related vascular complication	Any device-related vascular complication	Discharge, 1-months, 6-months
Residual stenosis, Degree of dissection, Final Flow	Angiographic analysis from DSA	Index procedure
Procedural time duration, amount of contrast media and radiation dose.	Procedural analysis	Index procedure
Centralized analysis of the angiographic parameters	Centralized analysis of the angiographic parameters	Index procedure
Stent Implantation	Need for stent implantation on the procedural vascular access axe.	Index procedure
Functional capacity of the inferior limbs	Functional capacity of the inferior limbs at 6 months.	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.	6-months

Collaborators and Investigators

• Sponsor: Rede Optimus Hospitalar SA
• Investigators: Study Director: Flavio Ribichini, MD, PhD, AOUI, Verona

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: TAVI; Calcification; Ilio-femoral arteries
• Other Study ID Numbers: RO-230301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No