Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent

Coronary Artery Disease (CAD) Clinical Trial

— DEBATE  

Official title:

Drug Eluting Balloon Angioplasty in Tunisian Population Versus Everolimus Platinum Chrome Stent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516446
• Other study ID #: santemilitaire9
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: General Administration of Military Health, Tunisia
• Contact: Aymen Noamen, MD
• Phone: 0021620215773
• Email: no.aymen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• DEB 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.
• DES for de Novo Lesions
The latest generation DES : everolimus-eluting platinum-chromium alloy coronary stent system (Promus Premier, Promus Elite)

Locations

Country	Name	City	State
Tunisia	Military hospital of Tunis	Tunis

Sponsors (2)

Lead Sponsor	Collaborator
General Administration of Military Health, Tunisia	B. Braun Medical International Trading Company Ltd.

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late lumen loss (LLL)	late lumen loss between Drug Eluting Balloon treated group and Drug Eluting Stents treated group evaluated by quantitative coronary analysis	Follow-up coronary angiography at 12 months after the percutaneous coronary intervention
Secondary	rate of major adverse cardiac events (MACE)	Major adverse cardiac event defined as the composite of myocardial infarction, target vessel revascularization and cardiac death	6 months and 12 months after percutaneous coronary intervention