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

NCT02542007 | Completed DMC

• 1 other identifier: RECOVERY Combo 2015-01
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 15

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.

Conditions

Coronary Arteriosclerosis

Keywords

intracoronary stent; drug eluting stent; sirolimus; endothelial progenitor cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 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

Study Arms (2)

OrbusNeich Combo stent™

EXPERIMENTAL

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™

Nano Polymer-free sirolimus-eluting stent system

ACTIVE COMPARATOR

The Nano polymer-free sirolimus-eluting stent produced by LePu medical.

Device: sirolimus-eluting stent system

Interventions

OrbusNeich Combo stent™ DEVICE

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.

OrbusNeich Combo stent™

sirolimus-eluting stent system DEVICE

Also known as: Nano Polymer-free sirolimus-eluting stent system

Nano Polymer-free sirolimus-eluting stent system

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• OrbusNeich: lead
• CCRF Inc., Beijing, China: collaborator
• OrbusNeich Medical (Shenzhen), Co. Ltd.: collaborator

Study Sites (15)

Daqing General Oilfield Hospital

Daqing, Heilongjiang, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

China Japan Union Hospital of Jilin University

Changchun, Jilin, China

Location

The people Hospital of Liaoning Province

Shenyang, Liaoning, China

Location

The Secondary Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Kunming General Hospital of Chengdu Military region

Kunming, Yunnan, China

Location

Beijing Chao Yang Hospital

Beijing, China

Location

The Military General Hospital of Beijing PLA

Beijing, China

Location

Bethune International Peace Hospital

Shijiazhuang, China

Location

TEDA International Cardiovascular Hospital

Tianjin, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

Tianjing Chest Hospital

Tianjing, China

Location

The First Affiliated Hospital of the Fourth Military Medical University

Xi'an, Shanxi, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 4, 2015
• Study Start: May 1, 2015
• Primary Completion: May 27, 2017
• Study Completion: June 10, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

CN (15)