In-Stent RestenosisPhase 3ISRIINCT01255956
Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter (RESTENOZA)
A Phase 3 study testing Rapamycin eluting stent implantation and Paclitaxel eluting balloon catheter in people with In-Stent Restenosis, run by Medical University of Warsaw at 4 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-Stent Restenosis
- What is being tested?
- Rapamycin eluting stent implantation and Paclitaxel eluting balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesPoland
- Study dates
- Dec 2010to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Poland4 sites, 4 recruiting
- Recruiting
II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow
Krakow, Kopernika 17, 31-500
Jacek Legutko, MD, PhD, +48 12 424 71 81
Jacek Legutko, MD, PhD
- Recruiting
Klinika Kardiologii z Kliniką Kardiochirurgii Uniwersyteckiego Szpitala Klinicznego w Lodzi
Lodz, Kniaziewicza 1/5, 91-347
Zbigniew Peruga, MD, PhD, +48 42 251 62 21
Zbigniew Peruga, MD, PhD
- Recruiting
Instytut Kardiologii w Warszawie-Aninie
Warsaw, Alpejska 42, 04-628
Adam Witkowski, MD, PhD, +48 22 812 41 64
Adam Witkowski, MD, PhD
- Recruiting
Katedra i Klinika Kardiologii Warszawskiego Uniwersytetu Medycznego
Warsaw, Banacha 1a, 02-097
Janusz Kochman, MD, PhD, +48 22 599 19 58
Janusz Kochman, MD, PhD
About this study
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
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.
Read the 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)
- Conditions
- In-Stent Restenosis
- Being tested
- Rapamycin eluting stent implantation, Paclitaxel eluting balloon catheter
- Keywords
- restenosis, ISR, in-stent restenosis, drug eluting stent, rapamycin eluting stent, paclitaxel eluting balloon catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapamycin eluting stent implantationDevice
Rapamycin eluting stent implantation for in-stent restenosis treatment
Paclitaxel eluting balloon catheterDevice
Paclitaxel eluting balloon catheter for in-stent restenosis treatment
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin eluting stent | Experimental | Patients treated with rapamycin eluting stent (n=100) Receives: Device: Rapamycin eluting stent implantation |
| Paclitaxel eluting balloon catheter | Experimental | Patients treated with paclitaxel eluting balloon catheter (n=100) Receives: Device: Paclitaxel eluting balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of repeated restenosis angiographically evidenced
Measured: at 9 months
Neointimal volume assessed by intravascular ultrasound (IVUS)
Measured: at 9 months
Late lumen loss and neointimal volume assessed by optical coherence tomography (OCT)
Measured: at 9 months
Secondary outcomes (6)
Incidence of repeated target lesion revascularization (TLR)
Measured: at 9 months
Incidence of repeated target vessel revascularization (TVR)
Measured: at 9 months
Incidence of death
Measured: at 9 months
Incidence of myocardial infarction
Measured: at 9 months
Incidence of brain stroke
Measured: at 9 months
Incidence of in-stent thrombosis
Measured: at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-Stent RestenosisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- KCRI
- Investigators
- Jacek Legutko, MD, PhD, Principal investigator, II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255956
- Sponsor's protocol ID
- Restenoza II 4.0
- Acronym
- ISRII
- Status last verified
- Jan 2011
- First submitted
- 6 Dec 2010
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01255956
- Acronym / sponsor ID
- ISRII / Restenoza II 4.0
- Conditions
- In-Stent Restenosis
- Keywords
- restenosis, ISR, in-stent restenosis, drug eluting stent, rapamycin eluting stent, paclitaxel eluting balloon catheter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- KCRI
- Study start
- Dec 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapamycin eluting stent | Experimental | Device: Rapamycin eluting stent implantationPatients treated with rapamycin eluting stent (n=100) |
| Paclitaxel eluting balloon catheter | Experimental | Device: Paclitaxel eluting balloon catheterPatients treated with paclitaxel eluting balloon catheter (n=100) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapamycin eluting stent implantationRapamycin eluting stent implantation for in-stent restenosis treatment | Device | Rapamycin eluting stent |
| Paclitaxel eluting balloon catheterPaclitaxel eluting balloon catheter for in-stent restenosis treatment | Device | Paclitaxel eluting balloon catheter |
Primary outcome
Incidence of repeated restenosis angiographically evidenced
Time frame: at 9 months
Neointimal volume assessed by intravascular ultrasound (IVUS)
Time frame: at 9 months
Late lumen loss and neointimal volume assessed by optical coherence tomography (OCT)
Time frame: at 9 months
6 secondary outcomes
Incidence of repeated target lesion revascularization (TLR)
Time frame: at 9 months
Incidence of repeated target vessel revascularization (TVR)
Time frame: at 9 months
Incidence of death
Time frame: at 9 months
Incidence of myocardial infarction
Time frame: at 9 months
Incidence of brain stroke
Time frame: at 9 months
Incidence of in-stent thrombosis
Time frame: at 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
Related trials for In-Stent Restenosis
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Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
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A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In-Stent Restenosis
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A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klinika Kardiologii z Kliniką Kardiochirurgii Uniwersyteckiego Szpitala Klinicznego w Lodzi
Lodz, Poland
Jacek Legutko, MD, PhD principal investigator
II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rapamycin eluting stent implantation and Paclitaxel eluting balloon catheter in people with In-Stent Restenosis, run by Medical University of Warsaw at 4 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of repeated restenosis angiographically evidenced (time frame: at 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2011.