NCT05516446

Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent

Drug Eluting Balloon Angioplasty in Tunisian Population Versus Everolimus Platinum Chrome Stent

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: General Administration of Military Health, Tunisia · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized, open-label, single-center, non-inferiority clinical trial to compare late lumen loss (LLL) at 12 months in Tunisian population undergoing coronary percutaneous intervention between Drug Eluting Balloon treated group and Everolimus platinum chrome stent treated group.

Detailed description

Drug eluting stents (DES) leave a permanent metal implant that interferes with vasomotion, endothelial function and vascular remodeling. the rigid structure and the pharmacological properties of DES could overcome acute complications related to balloon dilation and late complications related to in-stent restenosis. However, they do not restore normal arterial function after the procedure. Drug eluting balloons (DEB) offer an alternative to the implantation of a durable material. They release a transient antiproliferative drug. They promise potential advantages over DES as: * an ad integrum restitution of the endothelium and its vasomotor properties. * a reduction of late thrombosis risk. * the possibility of grafting on the treated segment. * avoid the problems of side-branch trapped in the treatment of bifurcations. * improve the profitability of non-invasive imaging (coroscanner, magnetic resonance imaging) during patient follow-up. DEB is validated for the treatment of in-stent restenosis, especially focal and on small caliber arteries. The use of DEB in de novo lesions has been the subject of several studies. This therapeutic option should be evaluated in the Tunisian context The aim of this clinical trial is to compare the results of angioplasty by DEB (SEQUENT PLEASE) versus last generation DES: coronary stent system in platinum chromium alloy with everolimus elution (Promus Premier and Promus Elite) The Primary endpoint: late lumen loss at 12 months. The Secondary endpoint: the major cardiovascular event rate (MACE).

Conditions

• Percutaneous Coronary Intervention (PCI)
• Coronary Artery Disease (CAD)
• De Novo Stenosis

Interventions

Type	Name	Description
DEVICE	DEB for de Novo Lesions	The surface of the SeQuent® Please NEO balloon is coated with Paclitaxel at a concentration of 3 μg Paclitaxel per mm² of balloon surface. The matrix composed of Paclitaxel and Iopromide (Paccocath technology) allows homogeneous release of the active ingredient through the vessel surface.
DEVICE	DES for de Novo Lesions	The latest generation DES : everolimus-eluting platinum-chromium alloy coronary stent system (Promus Premier, Promus Elite)

Timeline

• Start date: 2021-08-25
• Primary completion: 2022-11-01
• Completion: 2022-12-01
• First posted: 2022-08-25
• Last updated: 2022-08-25

Locations

1 site across 1 country: Tunisia