Clinical trial NCT05873842: TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
Official title: TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trans-femoral TAVI With Calcified Ilio-femoral Arteries
Keywords: TAVI
Calcification
Ilio-femoral arteries
Lead sponsor: Rede Optimus Hospitalar SA
Sponsor class: NETWORK
First posted: 2023-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with calcified ilio-femoral arteries eligible for trans-femoral TAVI

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility and safety on the trans-femoral (TF) approach
timeFrame: Index procedure - 1 Month
Secondary outcomes:
measure: MAEs
timeFrame: Within 30 days after index procedure
measure: Vascular and bleeding complications
timeFrame: Within 30 days after index procedure
measure: Device-related vascular complication
timeFrame: Discharge, 1-months, 6-months
measure: Residual stenosis, Degree of dissection, Final Flow
timeFrame: Index procedure
measure: Procedural time duration, amount of contrast media and radiation dose.
timeFrame: Index procedure
measure: Centralized analysis of the angiographic parameters
timeFrame: Index procedure
measure: Stent Implantation
timeFrame: Index procedure
measure: Functional capacity of the inferior limbs
timeFrame: 6-months
measure: Patency at the distal level of the vascular access site
timeFrame: 6-months
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: AOU Cardiology Ancona
city: Mestre
country: Italy
facility: AULLS3 Cardiology Mestre
city: Treviso
country: Italy
facility: AULSS2 Cardiology Treviso
city: Verona
country: Italy
facility: AOUI Cardiology Verona
city: Vicenza
country: Italy
facility: AULLS8 Cardiology Vicenza
Study officials:
affiliation: AOUI, Verona
name: Flavio Ribichini, MD, PhD
role: STUDY_DIRECTOR
References: