Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Artery Lesions

NCT ID: NCT02360709

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2021-04-30

Brief Summary

The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent system in the treatment of patients with de novo coronary artery lesions.

Detailed Description

This is a prospective, multi-center, single-arm observational registry trial planned to enroll 800 subjects. All 800 subjects enrolled will receive CRE8 stents. Clinical follow-up will be performed at 1 month, 6 months,12 months and annually up to 5 years after the procedure.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CRE8 group

CRE8 sirolimus-eluting stent

CRE8 sirolimus-eluting stent

Intervention Type: DEVICE

The CRE8 stent system consists of a sirolimus eluting coronary stent firmly held on the distal end of a semicompliant balloon catheter. This stent is made of cobalt chromium alloy and is coated with a thin carbon film.The outer surface of the stent has dedicated grooves for containing the pharmaceutical formulation, which is composed of the drug sirolimus and a mixture of long chain fatty acids.

Interventions

CRE8 sirolimus-eluting stent

The CRE8 stent system consists of a sirolimus eluting coronary stent firmly held on the distal end of a semicompliant balloon catheter. This stent is made of cobalt chromium alloy and is coated with a thin carbon film.The outer surface of the stent has dedicated grooves for containing the pharmaceutical formulation, which is composed of the drug sirolimus and a mixture of long chain fatty acids.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years and ≤ 75 years, male or female without pregnancy;
• Patients with clinical evidence of asymptomatic heart disease, stable or unstable angina, or old myocardial infarction;
• De novo lesions of native coronary arteries;
• Target vessel diameter between 2.25mm and 4.5 mm, and target lesion length ≤ 60mm by visual estimation;
• Target lesion diameter stenosis ≥ 70% by visual estimation;
• Each target lesion must be implanted the same stent (CRE8);
• Patients is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
• Patients with left ventricular ejection fraction ≥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 consents.

Exclusion Criteria

• Patients with acute myocardial infarction (AMI) within 72 hours;
• Chronic total occlusion lesion (TIMI flow 0 before procedure), Left main disease and/or triple-vessel lesion that might require treatment;
• 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 lesions;
• Patients who had received any other stent in the past one year;
• 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 allergic to aspirin, clopidogrel, ticagrelor, ticlopidine, heparin, contrast agent, sirolimus, polymer, Co-Cr alloy, or with contraindication to aspirin or clopidogrel or ticagrelor;
• Patients with life expectancy less than 1year;
• Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
• Patient is in the opinion of the investigator, unable to comply with the requirements of the study protocol;
• Patients who had underwent heart transplant surgery.

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

Sponsors

CID S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shubin Qiao, MD

Role: PRINCIPAL_INVESTIGATOR

Fu Wai Hospital, National Center for Cardiovasular disease

Locations

Fuwai Hospital,National Center for Cardiovasular disease

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shubin Qiao, MD

Role: CONTACT

qli@ccrfmed.com;qsbfw@sina.com

+86 13701237893

Facility Contacts

Shubin Qiao, MD

Role: primary

qsbfw@sina.com

+86 13701237893

Other Identifiers

CRE8-China-SA

Identifier Type: -

Identifier Source: org_study_id