Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-27 @ 4:14 PM
Study NCT ID:
NCT05650450
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-08
First Post:
2022-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease
Sponsor:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Organization:
Study Overview
Official Title:
A Hybrid Approach Evaluating A Drug-Coated Balloon in Combination With A New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease: The HYPER II Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYPER II
Brief Summary:
An observational study to evaluate safety and efficacy of the hybrid approach DES/DCB in the treatment of long diffuse de novo coronary artery disease
Detailed Description:
This is a prospective, non-randomized, single-arm, multi-center study aiming to assess the feasibility and the clinical outcomes of using the Restore DCB (Cardionovum GmbH, Bonn, Germany) in combination ("hybrid approach") with a new generation DES (type at operator's discretion) for the treatment of diffuse CAD (Coronary Artery Disease) encountered in daily clinical practice (lesion length \> 38 mm). The rationale of the proposed strategy derives from the characteristics of DCB in treating the atherosclerotic disease without leaving a permanent structure in the vessel especially in case of diffuse CAD -avoiding a long metallic, permanent cage within extended coronary segments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: