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

A Prospective, Multi-center, Single-arm Observational Registry Trial Evaluating the Safety and Efficacy of CRE8 Sirolimus-Eluting Stent in the Treatment of Patients With De Novo Coronary Artery Lesions

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: CRE8 sirolimus-eluting stent

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.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Fuwai Hospital,National Center for Cardiovasular disease
      • Contact: Shubin Qiao, MD; Phone Number: +86 13701237893; Email: qsbfw@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This trial plans to enroll 800 subjects with de novo coronary artery lesions. Patients with reference diameter between 2.25mm and 4.5 mm (by visual estimation) and lesion length not more than 60mm (by visual estimation) will be enrolled.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

CRE8 group; CRE8 sirolimus-eluting stent

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target lesion failure (TLF,device-oriented endpoint)	12months after the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Target lesion failure (TLF,device-oriented endpoint)	1month,6months,2years,3years,4years and 5years follow-up
The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations	1month,6months,12months and annually up to 5years follow-up
Stent thrombosis per ARC definition	1month,6months,12months and annually up to 5years follow-up
device and lesion success rates	immidiately after the procedure
clinical success rate	7 days after the procedure

Collaborators and Investigators

• Sponsor: CID S.p.A.
• Investigators: Principal Investigator: Shubin Qiao, MD, Fu Wai Hospital, National Center for Cardiovasular disease

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 5, 2015
• First Posted (Estimate): February 11, 2015

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: CRE8-China-SA