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 (RECOVERY)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Arteriosclerosis
• Intervention / Treatment: Device: OrbusNeich Combo stent™; Device: sirolimus-eluting stent system

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 Type: Interventional
• Enrollment (Actual): 440
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Nano Polymer-free sirolimus-eluting stent system; The Nano polymer-free sirolimus-eluting stent produced by LePu medical.	Device: sirolimus-eluting stent system; Other Names: Nano Polymer-free sirolimus-eluting stent system

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: OrbusNeich
• Collaborators: CCRF Inc., Beijing, China; OrbusNeich Medical (Shenzhen), Co. Ltd.
• Investigators: Principal Investigator: Tao Ling, M.D., The First Affiliated Hospital of the Fourth Medical University; Principal Investigator: Xu Bo, M.D, The Secondary Affiliated Hospital of Harbin University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 27, 2017
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 2, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: drug eluting stent; sirolimus; endothelial progenitor cells; intracoronary stent
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: RECOVERY Combo 2015-01