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

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: Unknown
• Conditions: In-Stent Restenosis
• Intervention / Treatment: Device: Rapamycin eluting stent implantation; Device: Paclitaxel eluting balloon catheter

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: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Incidence of repeated restenosis angiographically evidenced	at 9 months
Neointimal volume assessed by intravascular ultrasound (IVUS)	at 9 months
Late lumen loss and neointimal volume assessed by optical coherence tomography (OCT)	at 9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of repeated target lesion revascularization (TLR)	at 9 months
Incidence of repeated target vessel revascularization (TVR)	at 9 months
Incidence of death	at 9 months
Incidence of myocardial infarction	at 9 months
Incidence of brain stroke	at 9 months
Incidence of in-stent thrombosis	at 9 months

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: KCRI
• Investigators: Principal Investigator: Jacek Legutko, MD, PhD, II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: December 6, 2010
• First Submitted That Met QC Criteria: December 7, 2010
• First Posted (Estimate): December 8, 2010

Study Record Updates

• Last Update Posted (Estimate): January 25, 2011
• Last Update Submitted That Met QC Criteria: January 24, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: drug eluting stent; restenosis; in-stent restenosis; ISR; rapamycin eluting stent; paclitaxel eluting balloon catheter
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Paclitaxel; Sirolimus
• Other Study ID Numbers: Restenoza II 4.0