Clinical trial NCT02360709: Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Artery Lesions
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: CID S.p.A.
Sponsor class: INDUSTRY
First posted: 2015-02-11
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Target lesion failure (TLF,device-oriented endpoint)
timeFrame: 12months after the procedure
Secondary outcomes:
measure: Target lesion failure (TLF,device-oriented endpoint)
timeFrame: 1month,6months,2years,3years,4years and 5years follow-up
measure: The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations
timeFrame: 1month,6months,12months and annually up to 5years follow-up
measure: Stent thrombosis per ARC definition
timeFrame: 1month,6months,12months and annually up to 5years follow-up
measure: device and lesion success rates
timeFrame: immidiately after the procedure
measure: clinical success rate
timeFrame: 7 days after the procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital,National Center for Cardiovasular disease
state: Beijing
Study officials:
affiliation: Fu Wai Hospital, National Center for Cardiovasular disease
name: Shubin Qiao, MD
role: PRINCIPAL_INVESTIGATOR
References: