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

OrbusNeich15 sites in 1 country440 target enrollmentMay 2015

ConditionsCoronary Arteriosclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Arteriosclerosis
Sponsor: OrbusNeich
Enrollment: 440
Locations: 15
Primary Endpoint: In-segment late lumen loss (LLL)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

June 10, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

OrbusNeich

Responsible Party

Sponsor

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;

Outcomes

Primary Outcomes

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 Outcomes

In-stent late lumen loss (LLL)(9 months post-procedure)
In-stent and In-segment minimal lumen diameter (MLD)(9 months post-procedure)
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 and In-segment binary restenosis (BR)(9 months post-procedure)
Definite and probable stent thrombosis (ST)(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)