Clinical trial NCT02542007: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Arteriosclerosis
Keywords: intracoronary stent
drug eluting stent
sirolimus
endothelial progenitor cells
Lead sponsor: OrbusNeich
Sponsor class: INDUSTRY
Collaborators: name: CCRF Inc., Beijing, China
name: OrbusNeich Medical (Shenzhen), Co. Ltd.
First posted: 2015-09-04
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-segment late lumen loss (LLL)
timeFrame: 9 months post-procedure
Secondary outcomes:
measure: Device-oriented target lesion failure (TLF)
timeFrame: 30 days, 6 months, 12 months and annually up to 5 years
measure: Patient-oriented composite endpoint
timeFrame: 30 days, 6 months, 12 months and annually up to 5 years
measure: In-stent late lumen loss (LLL)
timeFrame: 9 months post-procedure
measure: In-stent and In-segment binary restenosis (BR)
timeFrame: 9 months post-procedure
measure: In-stent and In-segment minimal lumen diameter (MLD)
timeFrame: 9 months post-procedure
measure: Definite and probable stent thrombosis (ST)
timeFrame: 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
Other outcomes:
Locations:
city: Daqing
country: China
facility: Daqing General Oilfield Hospital
state: Heilongjiang
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Changchun
country: China
facility: China Japan Union Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The people Hospital of Liaoning Province
state: Liaoning
city: Taiyuan
country: China
facility: The Secondary Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Kunming
country: China
facility: Kunming General Hospital of Chengdu Military region
state: Yunnan
city: Beijing
country: China
facility: Beijing Chao Yang Hospital
city: Beijing
country: China
facility: The Military General Hospital of Beijing PLA
city: Shijiazhuang
country: China
facility: Bethune International Peace Hospital
city: Tianjing
country: China
facility: Tianjing Chest Hospital
city: Tianjin
country: China
facility: TEDA International Cardiovascular Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Xi'an, Shanxi
country: China
facility: The First Affiliated Hospital of the Fourth Military Medical University
Study officials:
affiliation: The First Affiliated Hospital of the Fourth Medical University
name: Tao Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Secondary Affiliated Hospital of Harbin University
name: Xu Bo, M.D
role: PRINCIPAL_INVESTIGATOR
References: