Who is sponsoring NCT04142541?

NCT04142541 is sponsored by Contego Medical, Inc..

What condition does NCT04142541 study?

NCT04142541 studies Carotid Artery Stenosis.

Is NCT04142541 still recruiting?

NCT04142541 is currently completed. Last updated 21 November 2022.

Last reviewed 2022-11-21 · How we verify

NCT04142541: PERFORMANCE

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

Evaluation of the 3-in-1 Neuroguard IEP System for Carotid Artery Stenosis

Completed NA Last updated 21 November 2022

What this trial tests

NA trial testing Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System) in Carotid Artery Stenosis in 67 participants. Completed in 17 February 2020.

Timeline

28 February 2018

Primary endpoint
18 March 2019

17 February 2020

Quick facts

Lead sponsor	Contego Medical, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	28 February 2018
Primary completion	18 March 2019
Estimated completion	17 February 2020
Sites	6 locations across Italy, Germany

Drugs / interventions tested

Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)

Conditions studied

Carotid Artery Stenosis — all drugs for Carotid Artery Stenosis →

Sponsor

Contego Medical, Inc. — full company profile →

Who can join

18 and older, any sex, with Carotid Artery Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Neuroguard IEP System is a 3-in-1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an outer sheath. The PERFORMANCE I study is a multi-center, prospective, single arm open label study to evaluate the safety and feasibility of the Neuroguard IEP System for the treatment of carotid artery stenosis. The primary endpoint will be the proportion of patients with Major Adverse Events (MAE) reported within 30 days from the index procedure. The primary objective of the PERFORMANCE I study is to evaluate the safety and feasibility of the Neuroguard IEP Carotid Stent System when used in patients with clinically significant carotid artery stenosis requiring revascularization.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.
Langhoff R, Petrov I, Kedev S, Milosevic Z, et al · · 2022 · cited 6× · PMID 36229946 · DOI 10.1002/ccd.30410

Verify or expand the search:

Other recruiting trials for Carotid Artery Stenosis

Currently open trials in the same condition.

NCT07370246 — CAS for Stenosis With High-risk Features for CEA · NA · recruiting
NCT07247864 — Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting · NA · recruiting
NCT06924593 — Study on the Trans-Carotid Artery Occlusion Shunt System · NA · recruiting
NCT07034157 — A Real-World Study on Ultrasound-Based Screening and Integrated Therapeutic Strategies for Patients With Concomitant Cor · recruiting
NCT06936176 — Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial) · NA · recruiting

Other Contego Medical, Inc. trials

Trials by the same sponsor.

NCT05845710 — Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III) · NA · completed
NCT03271710 — Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the Vanguard IEP System · NA · 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 NCT04142541 (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 Contego Medical, Inc.
Last refreshed: 21 November 2022

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/NCT04142541.

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