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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Medical University of Warsaw.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Krakow Cardiovascular Research Institute
Information provided by:
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01255956
First received: December 6, 2010
Last updated: January 24, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
In-Stent Restenosis
Device: Rapamycin eluting stent implantation
Device: Paclitaxel eluting balloon catheter
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • Incidence of repeated restenosis angiographically evidenced [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • Neointimal volume assessed by intravascular ultrasound (IVUS) [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • Late lumen loss and neointimal volume assessed by optical coherence tomography (OCT) [ Time Frame: at 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of repeated target lesion revascularization (TLR) [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of repeated target vessel revascularization (TVR) [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of death [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of myocardial infarction [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of brain stroke [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of in-stent thrombosis [ Time Frame: at 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255956

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

No publications provided

Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01255956     History of Changes
Other Study ID Numbers: Restenoza II 4.0
Study First Received: December 6, 2010
Last Updated: January 24, 2011
Health Authority: Poland: Ministry of Health

Keywords provided by Medical University of Warsaw:
restenosis
ISR
in-stent restenosis
drug eluting stent
rapamycin eluting stent
paclitaxel eluting balloon catheter

Additional relevant MeSH terms:
Paclitaxel
Sirolimus
Everolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014