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

Coronary Arteriosclerosis Clinical Trial

— RECOVERY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542007
• Other study ID #: RECOVERY Combo 2015-01
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: June 10, 2021

Study information

• Verified date: September 2021
• Source: OrbusNeich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: June 10, 2021
• Est. primary completion date: May 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Device:
• OrbusNeich Combo stent™
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.
• sirolimus-eluting stent system

Locations

Country	Name	City	State
China	Beijing Chao Yang Hospital	Beijing
China	The Military General Hospital of Beijing PLA	Beijing
China	China Japan Union Hospital of Jilin University	Changchun	Jilin
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Daqing General Oilfield Hospital	Daqing	Heilongjiang
China	Kunming General Hospital of Chengdu Military region	Kunming	Yunnan
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The people Hospital of Liaoning Province	Shenyang	Liaoning
China	Bethune International Peace Hospital	Shijiazhuang
China	The Secondary Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	TEDA International Cardiovascular Hospital	Tianjin
China	Tianjin Medical University General Hospital	Tianjin
China	Tianjing Chest Hospital	Tianjing
China	The First Affiliated Hospital of the Fourth Military Medical University	Xi'an, Shanxi

Sponsors (3)

Lead Sponsor	Collaborator
OrbusNeich	CCRF Inc., Beijing, China, OrbusNeich Medical (Shenzhen), Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	In-stent late lumen loss (LLL)		9 months post-procedure
Secondary	In-stent and In-segment binary restenosis (BR)		9 months post-procedure
Secondary	In-stent and In-segment minimal lumen diameter (MLD)		9 months post-procedure
Secondary	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