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Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)

NCT05637983 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2022-12-06

No results posted yet for this study

Summary

Recent observational data showed a marked reduction of vascular and bleeding complications by the use of ultrasound(US)-guided femoral artery puncture to gain the vascular access and guide the implantation of the Perclose ProGlide® vascular closure system.

We aimed to compare in a 1:1 randomized fashion the effect of US-guided femoral puncture and Perclose ProGlide® implantation optimization vs fluoroscopy-guided puncture followed by Perclose ProGlide/ ProStyle implantation (standard approach) during TAVR.

Conditions

  • Transcatheter Aortic Valve Replacement

Interventions

PROCEDURE

US-guided femoral puncture vs Fluoroscopy-guided puncture

US-guided femoral puncture and Perclose ProGlide®/Prostyle implantation compared to Fluoroscopy-guided puncture and Perclose ProGlide®/Prostyle in TAVR

Sponsors & Collaborators

  • Nicolaus Copernicus University

    collaborator OTHER

  • Fondazione Toscana Gabriele Monasterio

    lead OTHER

Principal Investigators

  • Sergio Berti, MD · Fondazione Toscana Gabriele Monasterio

  • Eliano Navarese · Nicolaus Copernicus University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-04
Primary Completion
2023-11-30
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05637983 on ClinicalTrials.gov