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

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.

Study Overview

• Status: Recruiting
• Conditions: Transcatheter Aortic Valve Replacement
• Intervention / Treatment: Procedure: US-guided femoral puncture vs Fluoroscopy-guided puncture

Detailed Description

Transfemoral approach has become the standard route for a transcatheter aortic valve replacement (TAVR) procedure. Despite the technology improvements, vascular complications and access-related bleeding are frequently observed after TAVR and emerge predominantly within 30 days after TAVR. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 508
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergio Berti, MD; Phone Number: +39 3488964831; Email: berti@ftgm.it
• Study Contact Backup: Name: Eliano Navarese, MD; Phone Number: +39 3342594725; Email: elianonavarese@gmail.com

Study Locations

• Italy
  • MS
    • Massa, MS, Italy, 54100
      • Recruiting
      • Fondazione Toscana Gabriele Monasterio
      • Contact: Sergio Berti, MD; Phone Number: +39 0503152216; Email: berti@ftgm.it
      • Contact: Nataliya Pylypiv; Phone Number: +39 3891256513; Email: pylypivn@ftgm.it
      • Sub-Investigator: Anees Ali Ahmed Al Jabri, MD
      • Sub-Investigator: Marcello Ravani, MD
      • Sub-Investigator: Giuseppe Raffaele Trianni, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eligible Patients are male or female with severe aortic stenosis evaluated by the Heart Team as candidate to TAVR based on the current cardiology guidelines.

Exclusion Criteria:

• Refusal to participate in the study;
• Inability to provide written consent to the study protocol;
• Chronic immuno-suppressant therapy;
• Any concomitant condition which, in the opinion of the Investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological disorder);
• Enrolment in another study that could confound the results of this study;
• Life expectancy < 1 year;
• Any contraindication to TAVR procedure;
• Non transfemoral TAVR.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: US-guided femoral puncture; US-guided femoral puncture and Perclose ProGlide/Prostyle implantation during transcatheter aortic valve replacement (TAVR)	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
Active Comparator: Fluoroscopy-guided puncture; Fluoroscopy-guided puncture and Perclose ProGlide/Prostyle implantation during transcatheter aortic valve replacement (TAVR)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of CV mortality, vascular complications or access-related bleeding after TAVR at 30 days.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CV mortality		1 month
Vascular complications		1 month
Life-threatening or disabling bleeding	Fatal bleeding (BARC type 5) OR Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) or Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR Overt source of bleeding with drop in haemoglobin ≥5 g/dl or whole blood or packed red blood cells (RBCs) transfusion ≥4 units (BARC type 3b)	1 month
Major bleeding (BARC type 3a)	Overt bleeding either associated with a drop in the haemoglobin level of at least 3.0 g/dl or requiring transfusion of two or three units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND Does not meet criteria of life-threatening or disabling bleeding	1 month
Major vascular complications	Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudo-aneurysm OR Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, haematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, lifethreatening or major bleeding, visceral ischaemia, or neurological impairment OR Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment OR Any new ipsilateral lower extremity ischaemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR Surgery for access siterelated nerve injury OR Permanent access site-related nerve injury	1 month
Minor vascular complications	Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arteriovenous fistula, pseudoaneurysms, haematomas, percutaneous closure device failure) not leading to death, life-threatening or major bleeding, visceral ischaemia, or neurological impairment OR Distal embolization treated with embolectomy and/or thrombectomy and not resulting in amputation or irreversible end-organ damage OR Any unplanned endovascularstenting or unplanned surgical intervention not meeting the criteria for a major vascular complication OR Vascular repair or the need for vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization, or stent-graft) OR Percutaneous closure device failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning).	1 month

Collaborators and Investigators

• Sponsor: Fondazione Toscana Gabriele Monasterio
• Collaborators: Nicolaus Copernicus University
• Investigators: Principal Investigator: Sergio Berti, MD, Fondazione Toscana Gabriele Monasterio; Principal Investigator: Eliano Navarese, Nicolaus Copernicus University

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: November 25, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Versione: 1.0 del 18/06/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No