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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
440
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.
Daqing General Oilfield Hospital
Daqing, Heilongjiang, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
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.
Time frame: 9 months post-procedure
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)
Time frame: 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
Time frame: 30 days, 6 months, 12 months and annually up to 5 years
In-stent late lumen loss (LLL)
Time frame: 9 months post-procedure
In-stent and In-segment binary restenosis (BR)
Time frame: 9 months post-procedure
In-stent and In-segment minimal lumen diameter (MLD)
Time frame: 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
Time frame: 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
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China Japan Union Hospital of Jilin University
Changchun, Jilin, China
The people Hospital of Liaoning Province
Shenyang, Liaoning, China
The Secondary Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Kunming General Hospital of Chengdu Military region
Kunming, Yunnan, China
Beijing Chao Yang Hospital
Beijing, China
The Military General Hospital of Beijing PLA
Beijing, China
...and 5 more locations