Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter (RESTENOZA) (ISRII)
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
Sponsor: KCRI
This PHASE3 trial investigates In-Stent Restenosis and is currently ongoing. KCRI leads this study, which shows 6 recorded versions since 2010 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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 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)
Status Flow
Change History
6 versions recorded-
Sep 2025 — Present [monthly]
Unknown PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Unknown PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE3
Status: Unknown Status → Unknown
-
Jan 2021 — Jul 2024 [monthly]
Unknown Status PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Unknown Status PHASE3
▶ Show 1 earlier version
-
Jan 2017 — Jun 2018 [monthly]
Unknown Status PHASE3
First recorded
Dec 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- KCRI
- Medical University of Warsaw
For direct contact, visit the study record on ClinicalTrials.gov .