Suspended
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
What is being collected
Data Collection
Collected from today forward - ProspectiveWho is being recruted
Arterial Occlusive Diseases+5
+ Arteriosclerosis
+ Cardiovascular Diseases
From 18 to 75 Years
+22 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: November 2014
Summary
Principal SponsorCID S.p.A.
Study ContactShubin Qiao, MD
Last updated: January 27, 2026Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2014
Actual date on which the first participant was enrolled.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.
Official TitleA 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
Principal SponsorCID S.p.A.
Study ContactShubin Qiao, MD
Last updated: January 27, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
800 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial Ischemia
Criteria
9 inclusion criteria required to participate
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;
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13 exclusion criteria prevent from participating
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;
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Fuwai Hospital,National Center for Cardiovasular disease
Beijing, ChinaOpen Fuwai Hospital,National Center for Cardiovasular disease in Google MapsSuspendedOne Study Center