Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent (DEBATE)

General Administration of Military Health, Tunisia

Status: Enrolling

Conditions: De Novo Stenosis; Percutaneous Coronary Intervention (PCI); Coronary Artery Disease (CAD)

Treatments: Device: DEB for de Novo Lesions; Device: DES for de Novo Lesions

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT05516446

santemilitaire9

Details and patient eligibility

About

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.

Full 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).

Enrollment: 290 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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290 participants in 2 patient groups

DEB for de Novo Lesions

Experimental group

Description:

1. Preparation of the lesion by pre-dilation or another technique using a balloon undersized by 0.5 mm compared to the reference diameter of the artery and, if necessary, by a second balloon with a balloon/artery ratio of 0.8-1 inflated to 16-18 atm for best results. 2. when obtaining a stent-like result and in the absence of a major dissection less than grade C, a flow TIMI less than 3 and a residual stenosis of more than 30%, an angioplasty by a drug eluting balloon will be performed for an inflation of 30 seconds at 8-10 atm. 3. Otherwise, an angioplasty using a drug eluting stent will be proceeded. 4. Before removing the intracoronary guide, the operator will evaluate by Quantitative Coronary Arteriography (QCA) * The post-procedural TIMI flow. * the minimal post-procedural luminal diameter in mm.

Treatment:

Device: DEB for de Novo Lesions

DES for de Novo Lesions

Active Comparator group

Description:

1. The preparation of the lesion and the post dilation will be left to the discretion of the operator. 2. Angioplasty with Drug eluting balloon after pre dilatation will be performed. 3. Before removing the intracoronary guide, the operator will evaluate by Quantitative Coronary Arteriography (QCA) * The post-procedural TIMI flow. * the minimal post-procedural luminal diameter in mm.

Treatment:

Device: DES for de Novo Lesions