Clinical trial NCT05516446: Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent
Official title: Drug Eluting Balloon Angioplasty in Tunisian Population Versus Everolimus Platinum Chrome Stent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Coronary Intervention (PCI)
Coronary Artery Disease (CAD)
De Novo Stenosis
Keywords: Risk Assessment
Metals
Coronary Artery Disease
Treatment Outcome
Drug-Eluting Stents
Angioplasty, Balloon, Coronary
Randomized Controlled Trials as Topic
Coronary Restenosis
Lead sponsor: General Administration of Military Health, Tunisia
Sponsor class: NETWORK
Collaborators: name: B. Braun Medical International Trading Company Ltd.
First posted: 2022-08-25
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-center, randomized and controlled trial
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: late lumen loss (LLL)
timeFrame: Follow-up coronary angiography at 12 months after the percutaneous coronary intervention
Secondary outcomes:
measure: rate of major adverse cardiac events (MACE)
timeFrame: 6 months and 12 months after percutaneous coronary intervention
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military hospital of Tunis
Study officials:
affiliation: military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
name: Aymen Noamen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
name: Nadhem Hajlaoui, Pr
role: STUDY_DIRECTOR
affiliation: military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
name: Wafa Fehri, Pr
role: STUDY_CHAIR
References:
citation: Zhong PY, Ma Y, Shang YS, Niu Y, Bai N, Wang ZL. Efficacy of Drug-Coated Balloon Approaches for de novo Coronary Artery Diseases: A Bayesian Network Meta-Analysis. Front Cardiovasc Med. 2022 Jun 21;9:899701. doi: 10.3389/fcvm.2022.899701. eCollection 2022.