Carotid artery stenting with Neuroguard IEP System for Carotid Stenosis

Universitätsklinikum Leipzig, Leipzig, Germany
Carotid Stenosis+2 More ConditionsCarotid artery stenting with Neuroguard IEP System - Device
Eligibility
20 - 80
All Sexes

Study Summary

This trial is testing the safety and effectiveness of the Neuroguard IEP System, a 3-in-1 carotid stent delivery system, for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA).

Eligible Conditions
  • Carotid Stenosis
  • Carotid Artery Stenosis
  • Carotid Artery Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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3
FDA-approved ETA systems
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SELUTION SLR™ 018 DEB

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: 12 months, 24 months, 36 months

12 months
Neurological death
Rate of ipsilateral stroke
Target lesion revascularization (TLR)
Month 36
In-stent restenosis (ISR)
30 days
Major stroke
Minor stroke
Rate of stroke, death and myocardial infarction (MI)
Transient ischemic attack (TIA)
Day of procedure
Procedure success
Technical success

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Misago® RX Self-expanding Peripheral Stent
3
FDA-approved ETA systems
1
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Carotid artery stenting
1 of 1

Experimental Treatment

305 Total Participants · 1 Treatment Group

Primary Treatment: Carotid artery stenting with Neuroguard IEP System · No Placebo Group · N/A

Carotid artery stenting
Device
Experimental Group · 1 Intervention: Carotid artery stenting with Neuroguard IEP System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months, 24 months, 36 months

Who is running the clinical trial?

Contego Medical, Inc.Lead Sponsor
3 Previous Clinical Trials
286 Total Patients Enrolled
2 Trials studying Carotid Stenosis
173 Patients Enrolled for Carotid Stenosis
William A Gray, MDPrincipal InvestigatorMain Line Health
5 Previous Clinical Trials
801 Total Patients Enrolled
William A. Gray, MDPrincipal InvestigatorLankenau Heart Institute
3 Previous Clinical Trials
720 Total Patients Enrolled
1 Trials studying Carotid Stenosis
250 Patients Enrolled for Carotid Stenosis
Ralf Langhoff, MDPrincipal InvestigatorSankt Gertrauden Krankenhaus
1 Previous Clinical Trials
960 Total Patients Enrolled

Eligibility Criteria

Age 20 - 80 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to have a certain type of medical imaging test to be included in the study.
References

Frequently Asked Questions

Does this research endeavor accept those under seventy-five years of age as participants?

"To participate in the study, patients must be between 20 to 80 years. In contrast, there are 22 trials available for minors and 232 with an age limit of 65+." - Anonymous Online Contributor

Unverified Answer

Are there any American locations conducting this experiment?

"This clinical research is being conducted at the University of Iowa Hospital and Clinics in Iowa City, the University of Buffalo Neurosurgery in Buffalo, St. Francis Hospital in Roslyn and 7 other sites across the nation." - Anonymous Online Contributor

Unverified Answer

Are recruitment efforts for this research project still underway?

"Affirmative. The medical trial is currently enlisting volunteers, with the initial posting taking place on June 12th 2020 and most recent update happening on May 25th 2022. Seven centres are recruiting a total of 305 participants." - Anonymous Online Contributor

Unverified Answer

How many individuals are engaged in the current experiment?

"The sponsor of this trial, Contego Medical Inc., is aiming to enrol 305 people who meet the predetermined guidelines. They will be conducting the study at multiple sites including University of Iowa Hospital and Clinics in Iowa City, IA and University of Buffalo Neurosurgery in Buffalo, NY." - Anonymous Online Contributor

Unverified Answer

How can I join this clinical experiment?

"In order to be selected for this trial, applicants must possess a carotid ulcer and fall within the 20-80 year old age range. At present, 305 patients are being recruited." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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