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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)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02542007
First Posted: September 4, 2015
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
CCRF Inc., Beijing, China
OrbusNeich Medical (Shenzhen), Co. Ltd.
Information provided by (Responsible Party):
OrbusNeich
  Purpose
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.

Condition Intervention
Coronary Arteriosclerosis Device: OrbusNeich Combo stent™ Device: sirolimus-eluting stent system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by OrbusNeich:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Device-oriented target lesion failure (TLF) [ Time Frame: 30 days, 6 months, 12 months and annually up to 5 years ]
    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)

  • Patient-oriented composite endpoint [ Time Frame: 30 days, 6 months, 12 months and annually up to 5 years ]
    The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularization

  • 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) [ 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 ]
    Definite and probable stent thrombosis (ST) in acute, sub-acute, late and very late period per Academic Research Consortium (ARC) definition criteria


Enrollment: 440
Study Start Date: May 2015
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Nano Polymer-free 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542007


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

Responsible Party: OrbusNeich
ClinicalTrials.gov Identifier: NCT02542007     History of Changes
Other Study ID Numbers: RECOVERY Combo 2015-01
First Submitted: September 1, 2015
First Posted: September 4, 2015
Last Update Posted: October 6, 2017
Last Verified: October 2017

Keywords provided by OrbusNeich:
intracoronary stent
drug eluting stent
sirolimus
endothelial progenitor cells

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs