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

NCT02360709 | Unknown DMC

• 1 other identifier: CRE8-China-SA
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Target lesion failure (TLF,device-oriented endpoint)

  12months after the procedure

Secondary Outcomes (5)

• 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

Study Arms (1)

CRE8 group

CRE8 sirolimus-eluting stent

Device: CRE8 sirolimus-eluting stent

Interventions

CRE8 sirolimus-eluting stent 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.

CRE8 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CID S.p.A.: lead

Study Sites (1)

Fuwai Hospital,National Center for Cardiovasular disease

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Shubin Qiao, MD

  Fu Wai Hospital, National Center for Cardiovasular disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shubin Qiao, MD

CONTACT

+86 13701237893; qli@ccrfmed.com;qsbfw@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 11, 2015
• Study Start: November 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2021
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

CN (1)