ArticleLa Tunisie medicale
Drug-Eluting-Balloon Angioplasty in Tunisian population versus Everolimus-platinum-chrome-stent for de-novo coronary lesion.
Article in La Tunisie medicale. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05516446 (Drug Eluting Balloon Angioplasty in Tunisian Population Versus Everolimus Platinum Chrome Stent), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Drug Eluting Balloon Angioplasty in Tunisian Population Versus Everolimus Platinum Chrome Stent
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Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
research problemDrug-eluting balloon (DEB) angioplasty is a well-established treatment modality for in-stent restenosis, however its safety and efficacy in de-novo lesion especially in large vessel remains undetermined. Theoretically, DEB sight to eliminate stent thrombosis and reduce restenosis rates by leaving no metal behind.
aimTo compare the results of angioplasty of de novo lesions by DEB (SEQUENT PLEASE) versus DES (Promus Premier and Promus Elite) in a Tunisian population. THE ENDPOINTS will be primarily the Late Lumen Loss at 12 months and secondarily the Major Cardiovascular Event rate (MACE) at 12 months. INVESTIGATIVE PROCESS: This is a randomized controlled non-inferiority trial including 290 patients with chronic coronary disease or non-ST elevation myocardial infarction with de novo lesions. After coronarography, angiographic parameters concerning lesion location and quantitative analysis will be collected. Patients will be treated with DEB or DES according to their allocation group. Before removal of the guide, post-procedural angiographic parameters will be evaluated. Follow-up will be performed for 12 months and an angiographic examination will be performed either as an emergency or at 12 months. The significance level will be 5%. A univariate analysis will be performed to search for predictive factors of MACE. RESEARCH PLAN: Ethical considerations will be undertaken and respected. The study will run for 15 months starting August 25, 2021 Trial registration: NCT05516446.
Identifiers
37551532PMC10498760What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.