NL-OMON53733
Recruiting
Not Applicable
Randomized controlled clinical trial on the application of Heli-FX EndoAnchors in conjunction with the Endurant II/IIs endograft in infrarenal aortic aneurysms with a wide infrarenal neck - HERCULES Trial
Rijnstate Ziekenhuis0 sites28 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Rijnstate Ziekenhuis
- Enrollment
- 28
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older
- •Provided written informed consent
- •Clinical necessity for treatment of the AAA, according to the current
- •guidelines in the geographies participating
- •Elective repair
- •Eligible anatomy for treatment with the Endurant II/IIs endograft and Heli\-FX
- •EndoAnchors according to the IFU of both devices
- •Infrarenal neck diameter \>\= 28 mm and \<\=32 mm
- •Proximal neck length \>\=10mm
Exclusion Criteria
- •Anatomy outside the IFU of the Endurant II/IIs endograft and/or Heli\-FX
- •EndoAnchors
- •Planned use of AUI main body device
- •Patient is participating in another clinical study, potentially conflicting
- •with the outcomes of the current study.
- •Patient with eGFR \< 30 ml/min/1\.73m2 before the intervention
- •Patient\*s life expectancy \<2 years as judged by the investigator
- •Patient has a psychiatric or other condition that may interfere with the study
- •Patient has a known allergy to any device component
- •Patients with a systemic infection who may be at increased risk of
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Randomized clinical trial evaluating the applicability of remote rehabilitation in patients with lordosis (decrease, increase), kyphosis and scoliosisIRCT20230206057342N1Kerman University of Medical Sciences46
Recruiting
Phase 4
Randomized controlled clinical trial for the efficacy and safety of Kaihoujian inhalation for acute laryngitisacute laryngitisITMCTR1900002675Wangjing Hospital, China Academy of Chinese Medical Sciences
Completed
Not Applicable
Randomized controlled clinical trial evaluating the soft tissue attachment and morphology under different microbiological conditions comparing Zirconia and Titanium dental implants.K08.1Loss of teeth due to accident, extraction or local periodontal diseaseDRKS00008591Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich42
Completed
Not Applicable
Randomized, controlled, clinical trial for clinical, functional, and histomorphometrical evaluation of bone substitute materials in combination with PRF in use for socket preservatioBone- and soft tissue regeneration after tooth extractionK08.1Loss of teeth due to accident, extraction or local periodontal diseaseDRKS00019228niversitätsklinikum derGoethe-Universität Frankfurt am MainKlinik für Mund-, Kiefer- und Plastische Gesichtschirurgie72
Recruiting
Phase 3
Research Study of effect of Ayurvedic Drugs on School pressure or tentions in School ChildreCTRI/2020/01/022793Yashwant Ayurvedic College PGTRC Kodoli