NCT05873842

TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Rede Optimus Hospitalar SA · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trans-femoral TAVI With Calcified Ilio-femoral Arteries

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-07-22
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2023-05-24
• Last updated: 2025-05-16

Locations

5 sites across 1 country: Italy