Medtronic Vascular — Biomedical Watch V2

Traitements10programmes

Essais5liés

Publications3liées

SourceDBlocale

Traitements

10

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Medtronic Renal Denervation SystemThis is a prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document the long-term safety and effectiveness of renal denervation in a real world patient population with hypertension GSR DEFINE is the continuation of the Global SYMPLICITY Registry and collectively will enroll approximately 5000 patients with hypertension who undergo the renal denervation procedure, from over 300 sites worldwide. Subjects included in GSR DEFINE will be followed for a minimum of 1 year and up to 5 years post-procedure. Patients with uncontrolled hypertension will be enrolled in accordance with the inclusion criteria specified in the protocol.	Hypertension	À vérifier	À vérifier	Germany, Switzerland	À vérifier
Renal Denervation (Symplicity Spyral™)The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.	Hypertension, Maladie rénale chronique	Non applicable	À vérifier	United States, Australia, Belgium, France, Germany, Greece, Ireland, Monaco, …	À vérifier
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent SystemIt is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary stent system in the treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) in China.	Maladie coronarienne	Non applicable	À vérifier	China	À vérifier
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemIt is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.	Maladie coronarienne	Non applicable	À vérifier	China	À vérifier
Symplicity Spyral™ multi-electrode renal denervation systemThe purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertensive population.	Maladie rénale chronique	Non applicable	À vérifier	Australia, Belgium, Germany, Greece, Ireland, Malaysia, Netherlands, Taiwan, …	À vérifier
Renal Denervation (Symplicity Spyral™)The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.	Hypertension	Non applicable	À vérifier	United States, Australia, Belgium, France, Germany, Greece, Ireland, Monaco, Netherlands, Sweden, United Kingdom	À vérifier
Symplicity Spyral™ multi-electrode renal denervation systemThe purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertensive population.	Maladie rénale chronique	Non applicable	À vérifier	Australia, Belgium, Germany, Greece, Ireland, Malaysia, Netherlands, Taiwan, United Kingdom	À vérifier
Medtronic Renal Denervation SystemThis is a prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document the long-term safety and effectiveness of renal denervation in a real world patient population with hypertension GSR DEFINE is the continuation of the Global SYMPLICITY Registry and collectively will enroll approximately 5000 patients with hypertension who undergo the renal denervation procedure, from over 300 sites worldwide. Subjects included in GSR DEFINE will be followed for a minimum of 1 year and up to 5 years post-procedure. Patients with uncontrolled hypertension will be enrolled in accordance with the inclusion criteria specified in the protocol.	Hypertension	À vérifier	À vérifier	Germany, Switzerland	À vérifier
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemIt is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.	Maladie coronarienne	Non applicable	À vérifier	China	À vérifier
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemIt is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.	Maladie coronarienne	Non applicable	À vérifier	China	À vérifier

Essais cliniques

5

Molécule	Indication / population	Phase	NCT	Titre	Statut
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System	Maladie coronarienne	Non applicable	NCT03466151	RESOLUTE ONYX China RCT Study	COMPLETED
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System	Maladie coronarienne	Non applicable	NCT03471845	RESOLUTE ONYX China Single Arm Study	COMPLETED
Medtronic Renal Denervation System	Hypertension	À vérifier	NCT01534299	Global SYMPLICITY Registry (GSR) DEFINE	RECRUITING
Symplicity Spyral™ multi-electrode renal denervation system	Maladie rénale chronique	Non applicable	NCT07115953	Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension	RECRUITING
Renal Denervation (Symplicity Spyral™)	Hypertension	Non applicable	NCT05198674	SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN	ACTIVE_NOT_RECRUITING

Publications

3

Molécule	Indication / population	Titre	Journal	Date
Renal Denervation (Symplicity Spyral™)		Assessment of the safety and effectiveness of catheter-based renal denervation with the symplicity spyral system in patients with resistant hypertension: A single-center experience.	Clinical and experimental hypertension (New York, N.Y. : 1993)
Renal Denervation (Symplicity Spyral™)		Renal Denervation in Cardiovascular Diseases: Mechanisms, Evidence, and Expanding Applications.	Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Renal Denervation (Symplicity Spyral™)		Three-Year Durability of Radiofrequency Renal Denervation: SPYRAL HTN-ON MED.	Journal of the American Heart Association