Coronary Artery Disease (CAD) Clinical Trial
— DEBATEOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Tunisia | Military hospital of Tunis | Tunis |
Lead Sponsor | Collaborator |
---|---|
General Administration of Military Health, Tunisia | B. Braun Medical International Trading Company Ltd. |
Tunisia,
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
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 |
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