Who is sponsoring NCT03493971?

NCT03493971 is sponsored by Ospedale San Donato.

What drugs are being tested in NCT03493971?

Interventions in NCT03493971: Carotid revascularization performed using CAS, Carotid revascularization performed using CEA.

What condition does NCT03493971 study?

NCT03493971 studies Carotid Artery Diseases.

Is NCT03493971 still recruiting?

NCT03493971 is currently completed. Last updated 30 November 2023.

Last reviewed 2023-11-30 · How we verify

NCT03493971: BAROX

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Hemodynamics and Autonomic and Cognitive Performance After Carotid Revascularization Procedures

Completed NA Last updated 30 November 2023

What this trial tests

NA trial testing Carotid revascularization performed using CAS in Carotid Artery Diseases in 70 participants. Completed in 29 November 2023.

Timeline

21 March 2018

Primary endpoint
20 April 2022

29 November 2023

Quick facts

Lead sponsor	Ospedale San Donato
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	21 March 2018
Primary completion	20 April 2022
Estimated completion	29 November 2023
Sites	1 location across Italy

Drugs / interventions tested

Carotid revascularization performed using CAS
Carotid revascularization performed using CEA

Conditions studied

Carotid Artery Diseases — all drugs for Carotid Artery Diseases →

Sponsor

Ospedale San Donato — full company profile →

Who can join

Adults 18 to 75, any sex, with Carotid Artery Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Carotid revascularization procedures are performed for more than 87% of cases in patients with asymptomatic internal carotid stenosis (ICS), who are assumed to have a life expectancy of at least 5 years. Hence, the investigators aim to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in terms of long-term prognostic endpoints in patients with uneventful perioperative course. CEA and CAS, as a consequence of either surgical trauma or mechanical stimuli related to the compliance mismatch between the stented segment and the native artery, may perturb carotid baroreceptors function causing an impairment of cardiovascular autonomic control. Also, CEA and CAS result in different postoperative geometric features of carotid arteries that entail relevant modifications of rheological parameters, that may be associated with the risk of local complications. Finally, long-term and sustained cognitive benefits after CAS as compared to CEA are yet to be demonstrated.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Carotid Phase-Contrast Magnetic Resonance before Treatment: 4D-Flow versus Standard 2D Imaging.
Secchi F, Monti CB, Capra D, Vitale R, et al · · 2021 · cited 5× · PMID 34698250 · DOI 10.3390/tomography7040044
Comparison of the impact of carotid endarterectomy and stenting on autonomic and baroreflex regulations: a one-year follow-up randomized study.
Bari V, Nano G, Baroni I, De Angeli G, et al · · 2024 · cited 1× · PMID 39638832 · DOI 10.1038/s41598-024-81105-7
The impact of stenosis treatment on the hemodynamic crosstalk between carotid arteries.
Ceserani V, Conti M, Curcio N, Secchi F, et al · · 2025 · PMID 40594497 · DOI 10.1038/s41598-025-05466-3

Verify or expand the search:

Other recruiting trials for Carotid Artery Diseases

Currently open trials in the same condition.

NCT07296965 — Oral Microbiome in Carotid Atherosclerosis · recruiting
NCT06924593 — Study on the Trans-Carotid Artery Occlusion Shunt System · NA · recruiting
NCT06653387 — A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When · NA · recruiting
NCT06276374 — Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients · NA · recruiting
NCT06959628 — Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets · NA · recruiting

Other Ospedale San Donato trials

Trials by the same sponsor.

NCT07368816 — OEOd-Based Wound Dressing in Post-Surgical Diabetic Foot Ulcers · NA · completed
NCT04995640 — CILCA Arch Registry: Management and Outcomes of Open and Endovascular Repair · unknown
NCT04594889 — Comparison of Sirolimus vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia · NA · unknown
NCT03824626 — Biomechanical Reappraisal of Planning for Thoracic Endovascular Aortic Repair · unknown
NCT03838237 — Effect of Migalastat on Cardiac Involvement in Fabry Disease · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03493971 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ospedale San Donato
Last refreshed: 30 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03493971.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing