Loading clinical trials...
Loading clinical trials...
Drug Eluting Balloon Angioplasty in Tunisian Population Versus Everolimus Platinum Chrome Stent
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.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Military hospital of Tunis
Tunis, Tunisia
Start Date
August 25, 2021
Primary Completion Date
November 1, 2022
Completion Date
December 1, 2022
Last Updated
August 25, 2022
290
ESTIMATED participants
DEB for de Novo Lesions
DEVICE
DES for de Novo Lesions
DEVICE
Lead Sponsor
General Administration of Military Health, Tunisia
Collaborators
NCT06916520
NCT07444697
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions