Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter (RESTENOZA) (ISRII)

January 24, 2011 updated by: Medical University of Warsaw

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Alpejska 42
      • Warszawa, Alpejska 42, Poland, 04-628
        • Recruiting
        • Instytut Kardiologii w Warszawie-Aninie
        • Contact:
          • Adam Witkowski, MD, PhD
          • Phone Number: +48 22 812 41 64
    • Banacha 1a
      • Warszawa, Banacha 1a, Poland, 02-097
        • Recruiting
        • Katedra i Klinika Kardiologii Warszawskiego Uniwersytetu Medycznego
        • Contact:
          • Janusz Kochman, MD, PhD
          • Phone Number: +48 22 599 19 58
        • Principal Investigator:
          • Janusz Kochman, MD, PhD
    • Kniaziewicza 1/5
      • Lodz, Kniaziewicza 1/5, Poland, 91-347
        • Recruiting
        • Klinika Kardiologii z Kliniką Kardiochirurgii Uniwersyteckiego Szpitala Klinicznego w Lodzi
        • Contact:
          • Zbigniew Peruga, MD, PhD
          • Phone Number: +48 42 251 62 21
        • Principal Investigator:
          • Zbigniew Peruga, MD, PhD
    • Kopernika 17
      • Krakow, Kopernika 17, Poland, 31-500
        • Recruiting
        • II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow
        • Contact:
          • Jacek Legutko, MD, PhD
          • Phone Number: +48 12 424 71 81
        • Principal Investigator:
          • Jacek Legutko, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 18 years of age
  • symptomatic restenosis in bare metal stent implanted in native coronary artery
  • angina pectoris
  • ischemia evidenced by non-invasive diagnostic tests
  • angiographically evidenced in-stent restenosis > 50% assessed by quantitative coronary angiography (QCA)
  • vessel diameter > 2,5 mm

Clinical exclusion criteria:

  • myocardial infarction within less than past 72 hours
  • heart failure with left ventricular ejection fraction (LVEF) < 30%
  • chronic renal failure with significant impairment of glomerular filtration (creatinine > 2 mg/dl)
  • hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel, heparin, abciximab, rapamycin, paclitaxel
  • hypersensitivity to contrast
  • other diseases that may cause significant deterioration in long-term prognosis
  • acute or chronic inflammatory diseases
  • patients who are unwilling to consent for participation in the study

Angiographic exclusion criteria:

  • significant stenosis in left main coronary artery (LM)
  • multivessel disease qualifying for coronary artery bypass grafting (CABG)
  • anatomical localization and morphology that preclude optimal percutaneous intervention intervention's (PCI) result or intravascular ultrasound (IVUS) or optical coherence tomography performance
  • vessel diameter < 2,5 mm
  • restenotic lesion length > 30 mm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rapamycin eluting stent
Patients treated with rapamycin eluting stent (n=100)
Device: Rapamycin eluting stent implantation
Rapamycin eluting stent implantation for in-stent restenosis treatment
Experimental: Paclitaxel eluting balloon catheter
Patients treated with paclitaxel eluting balloon catheter (n=100)
Device: Paclitaxel eluting balloon catheter
Paclitaxel eluting balloon catheter for in-stent restenosis treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of repeated restenosis angiographically evidenced
Time Frame: at 9 months
at 9 months
Neointimal volume assessed by intravascular ultrasound (IVUS)
Time Frame: at 9 months
at 9 months
Late lumen loss and neointimal volume assessed by optical coherence tomography (OCT)
Time Frame: at 9 months
at 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of repeated target lesion revascularization (TLR)
Time Frame: at 9 months
at 9 months
Incidence of repeated target vessel revascularization (TVR)
Time Frame: at 9 months
at 9 months
Incidence of death
Time Frame: at 9 months
at 9 months
Incidence of myocardial infarction
Time Frame: at 9 months
at 9 months
Incidence of brain stroke
Time Frame: at 9 months
at 9 months
Incidence of in-stent thrombosis
Time Frame: at 9 months
at 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Warsaw

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KCRI

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacek Legutko, MD, PhD, II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Restenoza II 4.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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