TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

Recruiting

• Conditions: Trans-femoral TAVI With Calcified Ilio-femoral Arteries
• Interventions: Device: Trans-femoral TAVI

• Registration Number: NCT05873842
• Lead Sponsor: Rede Optimus Hospitalar SA

Brief 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.

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 Timeline

• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-24
• Study Start: 2024-07-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IVL-assisted group	Trans-femoral TAVI	-
PTA-assisted group	Trans-femoral TAVI	-

Primary Outcome Measures

Name	Time	Method
Feasibility and safety on the trans-femoral (TF) approach	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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

AOU Cardiology Ancona; 🇮🇹 Ancona, Italy

AULLS3 Cardiology Mestre; 🇮🇹 Mestre, Italy

AULSS2 Cardiology Treviso; 🇮🇹 Treviso, Italy

AOUI Cardiology Verona; 🇮🇹 Verona, Italy

AULLS8 Cardiology Vicenza; 🇮🇹 Vicenza, Italy