Safety and Effectiveness Study of Combo Bio-engineered Sirolimus Eluting Stent (REMEDEE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
OrbusNeich
ClinicalTrials.gov Identifier:
NCT00967902
First received: August 26, 2009
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

To demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) compared to the Taxus® Liberté® Stent in the treatment of coronary artery lesions.


Condition Intervention Phase
Coronary Artery Lesions
Device: coronary stenting
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The REMEDEE Study: A Prospective, Randomized Study to Evaluate the Safety and Efficacy of an Abluminal Sirolimus Coated Bio-engineered Stent (Combo Bio-engineered Sirolimus Eluting Stent)

Resource links provided by NLM:


Further study details as provided by OrbusNeich:

Primary Outcome Measures:
  • In-stent late lumen loss of the Combo Stent compared to the TAXUS® Liberté® DES [ Time Frame: 9 months post-procedure. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause and cardiac mortality [ Time Frame: 30 days, 9 months, 1, 2, 3, 4, and 5 year ] [ Designated as safety issue: Yes ]
  • Myocardial infarction: Q-wave and non Q-wave, cumulative and individual [ Time Frame: 30 days, 9 months, 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
  • Major Adverse Cardiac Event (MACE) defined as a composite of death, MI (Q-wave or non Q-wave), emergent CABG, or target lesion revascularization by repeat PTCA or CABG [ Time Frame: Hospital discharge, 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Vascular complications from index procedure [ Time Frame: Up to hospital discharge ] [ Designated as safety issue: Yes ]
  • Rate of stent thrombosis, per ARC definition of definite and probable stent thrombosis further categorized as early, late or very late [ Time Frame: 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Change in human anti-murine antibody (HAMA) plasma levels [ Time Frame: 30 day and 9 month follow-up compared to baseline ] [ Designated as safety issue: Yes ]
  • Device success, defined as attainment of <50% residual stenosis of the target lesion using the Combo Stent [ Time Frame: Index procedure ] [ Designated as safety issue: No ]
  • Lesion success defined as attainment of < 50% residual stenosis using any percutaneous method [ Time Frame: Index procedure ] [ Designated as safety issue: No ]
  • Procedure success defined as lesion success without the occurrence of in-hospital MACE [ Time Frame: Up to hospital discharge ] [ Designated as safety issue: No ]
  • Clinically (ischemia)-driven target lesion revascularization [ Time Frame: 30 days, 9 months, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: No ]
  • Clinically (ischemia)-driven target vessel revascularization [ Time Frame: 30 days, 9 months, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: No ]
  • In-stent and in-segment angiographic binary restenosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • In-stent and in-segment minimum lumen diameter (MLD) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • In-stent, proximal and distal late lumen loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Neointimal hyperplasia volume and % in-stent volume obstruction as measured by intravascular ultrasound (IVUS) for patients receiving angiographic/IVUS follow-up [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target lesion failure (TLF) (defined as death, MI and ischemic target lesion revascularization (TLR)) [ Time Frame: 30 days, 9 months, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: November 2009
Estimated Study Completion Date: July 2015
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combo
The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.
Device: coronary stenting
Balloon dilatation of obstructive coronary artery disease with deployment of a metallic stent to scaffold the dilated lesion; stent incorporating sustained release of anti-proliferative agent to control neointimal proliferation and reocclusion; test device incorporates affinity surface for circulating EPCs
Active Comparator: Taxus® Liberté® Stent
Commercially available product
Device: coronary stenting
Balloon dilatation of obstructive coronary artery disease with deployment of a metallic stent to scaffold the dilated lesion; stent incorporating sustained release of anti-proliferative agent to control neointimal proliferation and reocclusion; test device incorporates affinity surface for circulating EPCs

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

General Inclusion Criteria

  • The patient must be ≥18 and ≤ 80 years of age;
  • Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, IIB, IIC, IIIB, IIIC, and/or objective evidence of myocardial ischemia);
  • Acceptable candidate for CABG;
  • The Patient is willing to comply with specified follow-up evaluations;
  • The Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Human Research Ethics Committee (HREC).

Angiographic Inclusion Criteria:

  • Single de novo or non-stented restenotic lesion in the target vessel;
  • Patients with two-vessel coronary disease, may have undergone successful treatment (<20% diameter stenosis by visual estimate) of the non-target vessel with approved devices up to and including the index procedure but must be prior to the index target vessel treatment. Any non-target vessel or lesion intended to be treated during the index procedure, cannot be an unprotected left main, ostial lesion, chronic total occlusion (CTO), heavily calcified, bifurcation, vein grafts, have angiographic evidence of thrombus, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty;
  • Target lesion located in a native coronary artery;
  • Target lesion (maximum length is 20 mm by visual estimate) covered by a single stent maximum 23 mm length for Combo Stent, and 24 mm in length for TAXUS® Liberté® (stent coverage including at least 3 mm of healthy vessel is recommended). The lesion length should be measured after pre-dilation procedure;
  • Reference vessel diameter must be ≥2.5 to ≤ 3.5 mm by visual estimate. The vessel diameter should be measured after pre-dilation procedure and after intra-coronary nitroglycerin if spasm is suspected;
  • Target lesion ≥50% and <100% stenosed by visual estimate.

Exclusion Criteria:

General Exclusion Criteria:

  • Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
  • Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (elevated troponin or CK-MB ≥2 times upper limit of normal) or >72 hours preceding the index procedure and CK and CK-MB have not returned to within normal limits at the time of procedure;
  • The patient is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate unresponsive prolonged chest pain;
  • Impaired renal function (serum creatinine >2.0 mg/dL or 177 μmol/l) or on dialysis;
  • Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3;
  • Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated;
  • Patient requires low molecular weight heparin (LMWH) treatment post-procedure or has received a dose of LMWH ≤8 hours prior to index procedure;
  • Patient has received any organ transplant or is on a waiting list for any organ transplant;
  • Patient has other medical illness (e.g., cancer, known malignancy, or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
  • Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, sirolimus, paclitaxel and/or contrast sensitivity that cannot be adequately pre-medicated;
  • Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies (HAMA);
  • Patient presents with cardiogenic shock;
  • Patient has current unstable cardiac arrhythmias that create hemodynamic instability;
  • Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion;
  • Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
  • Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up;

Angiographic Exclusion Criteria:

  • Unprotected left main coronary artery disease with ≥50% stenosis;
  • Ostial target lesion(s);
  • Totally occluded target vessel (TIMI flow 0);
  • Calcified target lesion(s) which cannot be successfully predilated;
  • Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
  • Angiographic evidence of thrombus in the target lesion(s);
  • Target lesion involving bifurcation with a side branch ≥2.0 mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require intervention of diseased side branch;
  • A significant (>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single stent;
  • Diffuse distal disease to target lesion with impaired runoff;
  • Left ventricular ejection fraction (LVEF) ≤30% (LVEF must be obtained within 6 months prior to the index procedure);
  • Pre-treatment with devices other than balloon angioplasty;
  • Prior stent within 10 mm of target lesion;
  • Intervention (PCI or bypass) of another lesion performed within 6 months before or planned within 30 days following the index procedure.
  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: NCT00967902

Locations
Australia, New South Wales
John Hunter Hospital
Newcastle, New South Wales, Australia, 2300
Sponsors and Collaborators
OrbusNeich
Investigators
Principal Investigator: Ian T Meredith, MBBS, PhD Monash University
Principal Investigator: Stephan Windecker, MD University of Bern
Principal Investigator: Alexandre Abizaid, MD Inst Dante Pazzanese of Cardiology
Study Director: Roxana Mehran, MD CardioVascular Research Foundation, Korea
Study Director: Alexandra Lansky, MD CardioVascular Research Foundation, Korea
  More Information

Publications:
Responsible Party: OrbusNeich
ClinicalTrials.gov Identifier: NCT00967902     History of Changes
Other Study ID Numbers: VP-0427
Study First Received: August 26, 2009
Last Updated: December 11, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Institutional Review Board
Brazil: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Ethics Committee
Malaysia: Ministry of Health
Netherlands: Medical Ethics Review Committee (METC)
Singapore: Health Sciences Authority

Keywords provided by OrbusNeich:
intracoronary stent
drug eluting stent
sirolimus
endothelial progenitor cells
Drug Eluting Stent

Additional relevant MeSH terms:
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014