Coronary Artery DiseaseNCT02360709
Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Artery Lesions
An observational study of Coronary Artery Disease, run by CID S.p.A. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CRE8 sirolimus-eluting stent
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Apr 2021
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital,National Center for Cardiovasular disease
Beijing, Beijing Municipality, 100044
Shubin Qiao, MD, +86 13701237893, qsbfw@sina.com
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- CRE8 sirolimus-eluting stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRE8 sirolimus-eluting stentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CRE8 group | CRE8 sirolimus-eluting stent Receives: Device: CRE8 sirolimus-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure (TLF,device-oriented endpoint)
Measured: 12months after the procedure
Secondary outcomes (5)
Target lesion failure (TLF,device-oriented endpoint)
Measured: 1month,6months,2years,3years,4years and 5years follow-up
The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations
Measured: 1month,6months,12months and annually up to 5years follow-up
Stent thrombosis per ARC definition
Measured: 1month,6months,12months and annually up to 5years follow-up
device and lesion success rates
Measured: immidiately after the procedure
clinical success rate
Measured: 7 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionJan 2017 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- CID S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shubin Qiao, MD, Principal investigator, Fu Wai Hospital, National Center for Cardiovasular disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360709
- Sponsor's protocol ID
- CRE8-China-SA
- Status last verified
- Mar 2015
- First submitted
- 3 Feb 2015
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02360709
- Acronym / sponsor ID
- CRE8-China-SA
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- CID S.p.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRE8 group | – | Device: CRE8 sirolimus-eluting stentCRE8 sirolimus-eluting stent |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRE8 sirolimus-eluting stentThe 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. | Device | CRE8 group |
Primary outcome
Target lesion failure (TLF,device-oriented endpoint)
Time frame: 12months after the procedure
5 secondary outcomes
Target lesion failure (TLF,device-oriented endpoint)
Time frame: 1month,6months,2years,3years,4years and 5years follow-up
The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations
Time frame: 1month,6months,12months and annually up to 5years follow-up
Stent thrombosis per ARC definition
Time frame: 1month,6months,12months and annually up to 5years follow-up
device and lesion success rates
Time frame: immidiately after the procedure
clinical success rate
Time frame: 7 days after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shubin Qiao, MD principal investigator
Fu Wai Hospital, National Center for Cardiovasular disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by CID S.p.A. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shubin Qiao, MD (+86 13701237893, qli@ccrfmed.com;qsbfw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (TLF,device-oriented endpoint) (time frame: 12months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.