Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent

Status Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT05516446
Study type	Interventional
Source	General Administration of Military Health, Tunisia
Contact	Aymen Noamen, MD
Phone	0021620215773
Email	no.aymen@gmail.com
Status	Recruiting
Phase	N/A
Start date	August 25, 2021
Completion date	December 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent — DEBATE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms