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)

OrbusNeich1 site in 1 country180 target enrollmentNovember 2009

ConditionsCoronary Artery Lesions

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Coronary Artery Lesions
Sponsor: OrbusNeich
Enrollment: 180
Locations: 1
Primary Endpoint: In-stent late lumen loss of the Combo Stent compared to the TAXUS® Liberté® DES
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

September 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

OrbusNeich

Responsible Party

Sponsor

Eligibility 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;

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);

Outcomes

Primary Outcomes

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

Time Frame: 9 months post-procedure.

Secondary Outcomes

Procedure success defined as lesion success without the occurrence of in-hospital MACE(Up to hospital discharge)
Clinically (ischemia)-driven target lesion revascularization(30 days, 9 months, 1, 2, 3, 4 and 5 years)
In-stent and in-segment angiographic binary restenosis(9 months)
Neointimal hyperplasia volume and % in-stent volume obstruction as measured by intravascular ultrasound (IVUS) for patients receiving angiographic/IVUS follow-up(9 months)
Vascular complications from index procedure(Up to hospital discharge)
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)
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)
Device success, defined as attainment of <50% residual stenosis of the target lesion using the Combo Stent(Index procedure)
Clinically (ischemia)-driven target vessel revascularization(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)
Change in human anti-murine antibody (HAMA) plasma levels(30 day and 9 month follow-up compared to baseline)
Lesion success defined as attainment of < 50% residual stenosis using any percutaneous method(Index procedure)
Target lesion failure (TLF) (defined as death, MI and ischemic target lesion revascularization (TLR))(30 days, 9 months, 1, 2, 3, 4 and 5 years)
In-stent and in-segment minimum lumen diameter (MLD)(9 months)
In-stent, proximal and distal late lumen loss(9 months)