NCT02542007CompletedNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- OrbusNeich
- Enrollment
- 440
- Locations
- 15
- Primary Endpoint
- In-segment late lumen loss (LLL)
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
In-segment late lumen loss (LLL)
Time Frame: 9 months post-procedure
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.
Secondary Outcomes
- In-stent late lumen loss (LLL)(9 months post-procedure)
- In-stent and In-segment minimal lumen diameter (MLD)(9 months post-procedure)
- Device-oriented target lesion failure (TLF)(30 days, 6 months, 12 months and annually up to 5 years)
- Patient-oriented composite endpoint(30 days, 6 months, 12 months and annually up to 5 years)
- In-stent and In-segment binary restenosis (BR)(9 months post-procedure)
- Definite and probable stent thrombosis (ST)(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)
Investigators
Study Sites (15)
Loading locations...
Similar Trials
Completed
Phase 2
Safety and Effectiveness Study of Combo Bio-engineered Sirolimus Eluting StentCoronary Artery LesionsNCT00967902OrbusNeich180
Completed
Not Applicable
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery LesionsAtherosclerosis, CoronaryIschemic Heart DiseaseAcute Coronary SyndromeCoronary Artery DiseaseMyocardial IschemiaAngina PectorisNCT02389946Biotronik, Inc.1,334
Completed
Phase 3
Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)Coronary Artery DiseaseNCT00232765Cordis Corporation1,058
Recruiting
Not Applicable
Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery StenosisPeripheral Artery DiseaseNCT04982367Acotec Scientific Co., Ltd166
Completed
Phase 3
The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions.Coronary Artery DiseaseNCT00235144Cordis Corporation353