Health TrialsbyHealthPanel

TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

ConditionTrans-femoral TAVI With Calcified Ilio-femoral Arteries
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRede Optimus Hospitalar SA

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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)

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: PTA-assisted group1 intervention
Group B: IVL-assisted group1 intervention

Trial outcomes

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

Time frame
Index procedure - 1 Month

Secondary outcomes

1

MAEs

30-day composite occurrence of major clinical events: all-cause death, myocardial infarction and stroke

Time frame
Within 30 days after index procedure
2

Vascular and bleeding complications

30-day occurrence of vascular and bleeding complications according to the VARC-3 definition

Time frame
Within 30 days after index procedure
3

Device-related vascular complication

Any device-related vascular complication

Time frame
Discharge, 1-months, 6-months
4

Residual stenosis, Degree of dissection, Final Flow

Angiographic analysis from DSA

Time frame
Index procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rede Optimus Hospitalar SA

Lead sponsor

Source ClinicalTrials.gov
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