deltatrials
Unknown PHASE3 INTERVENTIONAL 2-arm NCT01255956

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

Updated 6 times since 2017 Last updated: Jan 24, 2011 Started: Dec 31, 2010 Primary completion: Jul 31, 2012 Completion: Jul 31, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 7 months · monthly snapshotUnknown

Change History

6 versions recorded
  1. Sep 2025 — Present [monthly]

    Unknown PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Unknown PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE3

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE3

Show 1 earlier version
  1. 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

Sponsor contact:
  • KCRI
  • Medical University of Warsaw
Data source: Medical University of Warsaw

For direct contact, visit the study record on ClinicalTrials.gov .