W.L.Gore & Associates — Biomedical Watch V2

Traitements6programmes

Essais2liés

Publications3liées

SourceDBlocale

Traitements

6

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Actual device PFO closureMulti-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief	Migraine	Non applicable	À vérifier	United States	À vérifier
InnAVasc Arteriovenous Graft (IG) surgical implantThe goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are: Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months. Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months. Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.	Maladie rénale chronique	Non applicable	À vérifier	United States	À vérifier
Sham device PFO closureMulti-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief	Migraine	Non applicable	À vérifier	United States	À vérifier
Thienopyridine (clopidogrel or prasugrel)Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief	Migraine	Non applicable	À vérifier	United States	À vérifier
Actual device PFO closureMulti-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief	Migraine	Non applicable	À vérifier	United States	À vérifier
InnAVasc Arteriovenous Graft (IG) surgical implantThe goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are: Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months. Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months. Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.	Maladie rénale chronique	Non applicable	À vérifier	United States	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
InnAVasc Arteriovenous Graft (IG) surgical implant	Maladie rénale chronique	Non applicable	NCT04671771	A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease	RECRUITING
Actual device PFO closure	Migraine	Non applicable	NCT04100135	RELIEF — GORE® CARDIOFORM Septal Occluder Migraine Clinical Study	TERMINATED

Publications

3

Molécule	Indication / population	Titre	Journal	Date
Sham device PFO closure		Feasibility and safety of cryoballoon ablation for atrial fibrillation and closing patent foramen ovale without implantation: A pilot study.	Heart rhythm
Thienopyridine (clopidogrel or prasugrel)		Different duration of dual antiplatelet therapy after endovascular treatment for unruptured intracranial aneurysms.	Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia
Thienopyridine (clopidogrel or prasugrel)		Impact of dual antiplatelet therapy duration after percutaneous coronary intervention on outcomes in acute coronary syndrome patients with and without chronic kidney disease: a nationwide cohort study.	Renal failure