Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions

Study Overview
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Brief Summary
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To evaluate the safety, efficacy and deliverability of the Combo bio-engineered sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the treatment of patients with de novo stenotic lesions of native coronary artery.

Detailed Description
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This is a prospective, multi-center, open-label, non-inferiority, randomized controlled trial which plans to enroll 436 subjects. All subjects enrolled will be randomly assigned to the test group (n=218) and the control group (n=218). Subjects in the test group and the control group will receive Combo stents and Nano stents respectively.

Official Title
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RECOVERY: A Prospective, Multi-center, Randomized Controlled Trial Evaluating the Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions of Native Coronary Artery

Conditions
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Coronary Arteriosclerosis

Intervention / Treatment
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* Device: OrbusNeich Combo stent™
* Device: sirolimus-eluting stent system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinical evidence of asymptomatic or symptomatic ischemic heart disease, stable or unstable angina, old myocardial infarction; De novo lesions of native coronary arteries (lesions number ≤2); Target lesion located in one or two different vessels. The number of target lesions in one vessel shall be no more than one; Target vessel diameter between 2.5 and 4.0 mm by visual estimation. Target lesion length ≤ 32mm by visual estimation, which can be covered by one Combo stent with length 38mm or one Nano stent with length 36mm. It is suggested that the selected stent size should cover at least 2 mm (by visual estimation) of normal tissue on each side of the lesion; Target lesion diameter stenosis ≥ 70% by visual estimation; Each target lesion is permitted to implant only one stent at most, except bailout stent; Patients is eligible for PCI and is an acceptable candidate for CABG; Patients with left ventricular ejection fraction (LVEF) ≥40%; Patients who can understand the nature of the study, agree to participate and accept angiographic and clinical follow-up, and have provided written informed consent; Exclusion Criteria: Patients with acute myocardial infarction (AMI) within one week; Chronic total occlusion lesion (TIMI 0 flow), Left main disease, Ostial lesion, and/or triple-vessel lesion that might require treatment, bifurcation lesions with a side branch diameter >2.5mm or graft lesions; Heavily calcified or tortuous lesions which cannot be successfully pre-dilated, and lesions which are not suitable for stent delivery and deployment; In-stent restenosis; Thrombotic lesion; Patients who had received any other stent in the past six months; Patients with acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl); Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or with a history of active gastrointestinal bleeding, ulcer, cerebral hemorrhage or subarachnoid hemorrhage and stroke within 6 months; Patients who are allergic to aspirin, clopidogrel, ticagrelor, ticlopidine, heparin, contrast agent, sirolimus, stainless steel , polymer, or with contraindication to aspirin or clopidogrel or ticagrelor; Patients who had previously received murine therapeutic antibodies and exhibited sensitization through the production of HAMA; Patients with a life expectancy less than 1year; Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint; Patient who has received any organ transplant or is on a waiting list for any organ transplant; Patient is in the opinion of the investigator, unable to comply with the requirements of the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OrbusNeich Combo stent™<br>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: OrbusNeich Combo stent™<br>* 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.<br>|
| Active Comparator: Nano Polymer-free sirolimus-eluting stent system<br>The Nano polymer-free sirolimus-eluting stent produced by LePu medical. | Device: sirolimus-eluting stent system<br> <br> * Other names: Nano Polymer-free sirolimus-eluting stent system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment late lumen loss (LLL) | In-segment late lumen loss (LLL) refers to within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. | 9 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-oriented target lesion failure (TLF) | The device-oriented target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (i-TLR) | 30 days, 6 months, 12 months and annually up to 5 years | 
| Patient-oriented composite endpoint | The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularization | 30 days, 6 months, 12 months and annually up to 5 years | 
| In-stent late lumen loss (LLL) |  | 9 months post-procedure | 
| In-stent and In-segment binary restenosis (BR) |  | 9 months post-procedure | 
| In-stent and In-segment minimal lumen diameter (MLD) |  | 9 months post-procedure | 
| Definite and probable stent thrombosis (ST) | Definite and probable stent thrombosis (ST) in acute, sub-acute, late and very late period per Academic Research Consortium (ARC) definition criteria | acute (0-24 hours), sub-acute (24 Hours to 30 Days), late (30 Days to 1 year) and very late (1 year to 5 years) period per Academic Research Consortium (ARC) definition criteria | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracoronary stent, drug eluting stent, sirolimus, endothelial progenitor cells