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

NCT ID: NCT02542007

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2021-06-10

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.

Conditions

Coronary Arteriosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

OrbusNeich Combo stent™

Intervention Type: 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.

Nano Polymer-free sirolimus-eluting stent system

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

Group Type: ACTIVE_COMPARATOR

sirolimus-eluting stent system

Intervention Type: DEVICE

Interventions

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.

Intervention Type: DEVICE

sirolimus-eluting stent system

Intervention Type: DEVICE

Other Intervention Names

Nano Polymer-free sirolimus-eluting stent system

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CCRF Inc., Beijing, China

INDUSTRY

Sponsor Role: collaborator

OrbusNeich Medical (Shenzhen), Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

OrbusNeich

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tao Ling, M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of the Fourth Medical University

Xu Bo, M.D

Role: PRINCIPAL_INVESTIGATOR

The Secondary Affiliated Hospital of Harbin University

Locations

Daqing General Oilfield Hospital

Daqing, Heilongjiang, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Nanjing First Hospital

Nanjing, Jiangsu, China

China Japan Union Hospital of Jilin University

Changchun, Jilin, China

The people Hospital of Liaoning Province

Shenyang, Liaoning, China

The Secondary Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Kunming General Hospital of Chengdu Military region

Kunming, Yunnan, China

Beijing Chao Yang Hospital

Beijing, , China

The Military General Hospital of Beijing PLA

Beijing, , China

Bethune International Peace Hospital

Shijiazhuang, , 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, , China

Countries

China

Other Identifiers

RECOVERY Combo 2015-01

Identifier Type: -

Identifier Source: org_study_id