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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02360709
• Other study ID #: CRE8-China-SA
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2015
• Last updated: March 23, 2015
• Start date: November 2014
• Est. completion date: April 2021

Study information

• Verified date: March 2015
• Source: CID S.p.A.
• Contact: Shubin Qiao, MD
• Phone: +86 13701237893
• Email: qli[@]ccrfmed.com;qsbfw[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 2021
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
China	Fuwai Hospital,National Center for Cardiovasular disease	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
CID S.p.A.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure (TLF,device-oriented endpoint)		12months after the procedure	Yes
Secondary	Target lesion failure (TLF,device-oriented endpoint)		1month,6months,2years,3years,4years and 5years follow-up	Yes
Secondary	The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations		1month,6months,12months and annually up to 5years follow-up	Yes
Secondary	Stent thrombosis per ARC definition		1month,6months,12months and annually up to 5years follow-up	Yes
Secondary	device and lesion success rates		immidiately after the procedure	No
Secondary	clinical success rate		7 days after the procedure	No