Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT01255956
Brief Summary:
The aim of the study is to compare rapamycin eluting stent and paclitaxel eluting balloon catheter in the treatment of restenosis in bare metal stent.
Detailed Description:
Study aims:
* Clinical efficacy evaluation of different treatment's strategies, including periprocedural and long-term endpoints defined as: death, myocardial infarction, brain stroke, necessity of repeated revascularization
* Evaluation of intravascular ultrasound (IVUS) as an optimisation method for direct and long-term revascularization effects
* Evaluation of optical coherence tomography as an optimisation method for direct and long-term revascularization effects
* Evaluation of late lumen loss and neointimal hyperplasia in stent in long-term follow-up
* Analysis of direct and indirect medical costs of alternative treatment strategies
Study group:
200 patients with symptomatic restenosis evidenced angiographically in bare metal stent implanted in native coronary artery. Patients will be randomised to 2 therapeutic groups:
* Patients treated with rapamycin eluting stent (n=100)
* Patients treated with paclitaxel eluting balloon catheter (n=100)
Study:
NCT01255956
Study Brief:
Protocol Section:
NCT01255956