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

NCT00967902 | Completed Phase 2 DMC

• 1 other identifier: VP-0427
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Lesions

Keywords

intracoronary stent; drug eluting stent; sirolimus; endothelial progenitor cells

Outcome Measures

Primary Outcomes (1)

• In-stent late lumen loss of the Combo Stent compared to the TAXUS® Liberté® DES

  9 months post-procedure.

Secondary Outcomes (16)

• All-cause and cardiac mortality

  30 days, 9 months, 1, 2, 3, 4, and 5 year

• Myocardial infarction: Q-wave and non Q-wave, cumulative and individual

  30 days, 9 months, 1, 2, 3, 4, and 5 years

• 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

  Hospital discharge, 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure

• Vascular complications from index procedure

  Up to hospital discharge

• Rate of stent thrombosis, per ARC definition of definite and probable stent thrombosis further categorized as early, late or very late

  30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure

Study Arms (2)

Combo

EXPERIMENTAL

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

Taxus® Liberté® Stent

ACTIVE COMPARATOR

Commercially available product

Device: coronary stenting

Interventions

coronary stenting DEVICE

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

Combo; Taxus® Liberté® Stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• OrbusNeich: lead

Study Sites (1)

John Hunter Hospital

Newcastle, New South Wales, 2300, Australia

Location

Related Publications (1)

• Haude M, Lee SW, Worthley SG, Silber S, Verheye S, Erbs S, Rosli MA, Botelho R, Meredith I, Sim KH, Stella PR, Tan HC, Whitbourn R, Thambar S, Abizaid A, Koh TH, Den Heijer P, Parise H, Cristea E, Maehara A, Mehran R. The REMEDEE trial: a randomized comparison of a combination sirolimus-eluting endothelial progenitor cell capture stent with a paclitaxel-eluting stent. JACC Cardiovasc Interv. 2013 Apr;6(4):334-43. doi: 10.1016/j.jcin.2012.10.018. Epub 2013 Mar 20.

  PMID: 23523459 RESULT

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Roxana Mehran, MD

  CardioVascular Research Foundation

  STUDY DIRECTOR

• Alexandra Lansky, MD

  CardioVascular Research Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 28, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2015
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

AU (1)