Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT01255956
Status:
UNKNOWN
Last Update Posted:
2011-01-25
First Post:
2010-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter (RESTENOZA)
Sponsor:
Medical University of Warsaw
Organization:
Study Overview
Official Title:
Efficacy Evaluation of In-bare Metal Stent Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter. Study With Intravascular Ultrasound and Optical Coherence Tomography
Status:
UNKNOWN
Status Verified Date:
2011-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISRII
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)
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: