TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

NCT05873842 | Recruiting

• 1 other identifier: RO-230301
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Trans-femoral TAVI With Calcified Ilio-femoral Arteries

Keywords

TAVI; Calcification; Ilio-femoral arteries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• MAEs

  Within 30 days after index procedure

• Vascular and bleeding complications

  Within 30 days after index procedure

• Device-related vascular complication

  Discharge, 1-months, 6-months

• Residual stenosis, Degree of dissection, Final Flow

  Index procedure

• Procedural time duration, amount of contrast media and radiation dose.

  Index procedure

Study Arms (2)

PTA-assisted group

Device: Trans-femoral TAVI

IVL-assisted group

Device: Trans-femoral TAVI

Interventions

Trans-femoral TAVI DEVICE

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; PTA-assisted group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Rede Optimus Hospitalar SA: lead

Study Sites (5)

AOU Cardiology Ancona

Ancona, Italy

RECRUITING

AULLS3 Cardiology Mestre

Mestre, Italy

RECRUITING

AULSS2 Cardiology Treviso

Treviso, Italy

ACTIVE NOT RECRUITING

AOUI Cardiology Verona

Verona, Italy

RECRUITING

AULLS8 Cardiology Vicenza

Vicenza, Italy

RECRUITING

MeSH Terms

Conditions

Calcinosis

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Flavio Ribichini, MD, PhD

  AOUI, Verona

  STUDY DIRECTOR

Central Study Contacts

Azinwi Phina Muna, phd

CONTACT

+49 157 80 58 5869; trafic@redeoptimus.com

Cristian Di Biase, Phd

CONTACT

+49 176 89982768; Cristian.dibiase@redeoptimus.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: July 22, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)