Coronary Artery Disease (CAD), De Novo Stenosis, Percutaneous Coronary Intervention (PCI)
Conditions
Keywords
Risk Assessment, Metals, Coronary Artery Disease, Treatment Outcome, Drug-Eluting Stents, Angioplasty, Balloon, Coronary, Randomized Controlled Trials as Topic, Coronary Restenosis
Brief 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).
Interventions
DEVICEDEB 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.
DEVICEDES for de Novo Lesions
The latest generation DES : everolimus-eluting platinum-chromium alloy coronary stent system (Promus Premier, Promus Elite)
Sponsors
B. Braun Medical International Trading Company Ltd.
General Administration of Military Health, Tunisia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective, single-center, randomized and controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with silent ischemia, stable angina, unstable angina, or non-Q wave myocardial infarction. * a de Novo lesion on a never treated native artery. * A reference artery diameter between 2 mm and 4 mm. Non-inclusion criteria * Patients with STEMI in the acute phase or presenting a cardiogenic shock. * Patients with an allergy or a contraindication to double anti-platelet aggregation. * Pre-menopausal patients not using regularly an oral contraceptives or breast-feeding . * Patients with severe comorbidity or with an estimated survival of less than 12 months. * Dissected lesions or spontaneous dissections other than grade A or B requiring DES angioplasty. * In-stent restenosis. * Thrombotic lesions.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| late lumen loss (LLL) | Follow-up coronary angiography at 12 months after the percutaneous coronary intervention | late lumen loss between Drug Eluting Balloon treated group and Drug Eluting Stents treated group evaluated by quantitative coronary analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of major adverse cardiac events (MACE) | 6 months and 12 months after percutaneous coronary intervention | Major adverse cardiac event defined as the composite of myocardial infarction, target vessel revascularization and cardiac death |
Countries
Tunisia
Contacts
Primary ContactAymen Noamen, MD
Backup ContactAhmed Ben Amara, fellow
Outcome results
None listed