Coronary Artery DiseasePhase 3NCT02360423
Safety and Efficacy of the CRE8 Stent for the Treatment of De Novo Coronary Artery Lesions
A Phase 3 study testing CRE8 sirolimus-eluting stent and RESOLUTE zotarolimus-eluting stent in people with 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 and the RESOLUTE zotarolimus-eluting stent 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 and RESOLUTE zotarolimus-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Apr 2021
- Phase
- Phase 3
- 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
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 (lesions number ≤ 2);
- Target vessel diameter between 2.25 and 4.0 mm and target lesion length ≤ 27mm by visual estimation;
- Target lesion diameter stenosis ≥ 70% by visual estimation;
- Each target lesion is permitted to implant only one stent at most, except bailout stent;
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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 consent.
- 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 (lesions number ≤ 2);
- Target lesion diameter stenosis ≥ 70% by visual estimation;
- At least one target lesion with reference vessel diameter between 2.5mm and 4.0mm and requires 38mm stent exists;
- 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 consent.
Who cannot join
- Patients with acute myocardial infarction (AMI) within one week;
- Chronic total occlusion lesion (TIMI flow 0 before procedure), Left main disease and/or triple-vessel lesion that might require treatment, bifurcation lesions with a side branch diameter >2.5mm or graft lesions;
- 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 lesion;
- 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, zotarolimus, 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, Randomized Controlled Trial Evaluating the Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent Versus the RESOLUTE Zotarolimus-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 and the RESOLUTE zotarolimus-eluting stent in the treatment of patients with de novo coronary artery lesions.
Read the detailed description
This study consists of a randomized controlled cohort and a long stent observational cohort. The randomized controlled trial is a prospective, multi-center, non-inferior, randomized controlled trial. The control device (RESOLUTE zotarolimus-eluting stent) used in this trial was provided by Medtronic. RESOLUTE zotarolimus-eluting stent has been already approved by China Food and Drug Administration (CFDA) in 2009 and become commercially available in Chinese market. 400 patients enrolled in this trial will be randomly assigned to CRE8 group (n=200) and RESOLUTE group (n=200) in a 1:1 ratio. The long stent observational trial plans to enroll 30 consecutive patients. Patients in the observational cohort will receive the long CRE8 stent with length 38mm.All 430 patients will be required to receive clinical follow-up at 1 month, 6 months, 9 months, 12 months and annually up to 5 years after the procedure, and angiographic follow-up at 9 months after the procedure. The primary endpoint is in-stent LLL at 9 months after the procedure, and the secondary endpoints are device success rate, device-oriented cardiovascular composite endpoint, patient-oriented cardiovascular composite endpoint and stent thrombosis.
- Conditions
- Coronary Artery Disease
- Being tested
- CRE8 sirolimus-eluting stent, RESOLUTE zotarolimus-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 is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium alloy and is coated with i-carbofilm.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.
RESOLUTE zotarolimus-eluting stentDevice
The RESOLUTE stent is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium tungsten alloy. It has been approved by CFDA in 2009 and commercially available in Chinese market
| Study group | Role | What they receive |
|---|---|---|
| CRE8 group | Experimental | CRE8 sirolimus-eluting stent system Receives: Device: CRE8 sirolimus-eluting stent |
| RESOLUTE group | Active comparator | RESOLUTE zotarolimus-eluting stent system Receives: Device: RESOLUTE zotarolimus-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent late lumen loss (LLL)
Measured: 9months after the procedure
Secondary outcomes (7)
In-stent, proximal stent edge, distal stent edge and In-segment binary restenosis rate
Measured: 9months after the procedure
In-segment late lumen loss (LLL)
Measured: 9months after the procedure
Target lesion failure (TLF) rate
Measured: 1month, 6months, 9months, 12months and annually up to 5 years follow-up
Number of participants with stent thrombosis per ARC definition
Measured: 1month, 6months, 9months, 12months and annually up to 5 years follow-up
The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations
Measured: 1month, 6months, 9months, 12months and annually up to 5 years follow-up
device and lesion success rates
Measured: immediately 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 posted10 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionOct 2016 (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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
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
- NCT02360423
- Sponsor's protocol ID
- CRE8-China-RCT
- 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, Randomized Controlled Trial Evaluating the Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent Versus the RESOLUTE Zotarolimus-Eluting Stent in the Treatment of Patients With De Novo Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT02360423
- Acronym / sponsor ID
- CRE8-China-RCT
- Conditions
- Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- CID S.p.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 10 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 and the RESOLUTE zotarolimus-eluting stent in the treatment of patients with de novo coronary artery lesions.
Detailed description
This study consists of a randomized controlled cohort and a long stent observational cohort. The randomized controlled trial is a prospective, multi-center, non-inferior, randomized controlled trial. The control device (RESOLUTE zotarolimus-eluting stent) used in this trial was provided by Medtronic. RESOLUTE zotarolimus-eluting stent has been already approved by China Food and Drug Administration (CFDA) in 2009 and become commercially available in Chinese market. 400 patients enrolled in this trial will be randomly assigned to CRE8 group (n=200) and RESOLUTE group (n=200) in a 1:1 ratio. The long stent observational trial plans to enroll 30 consecutive patients. Patients in the observational cohort will receive the long CRE8 stent with length 38mm.All 430 patients will be required to receive clinical follow-up at 1 month, 6 months, 9 months, 12 months and annually up to 5 years after the procedure, and angiographic follow-up at 9 months after the procedure. The primary endpoint is in-stent LLL at 9 months after the procedure, and the secondary endpoints are device success rate, device-oriented cardiovascular composite endpoint, patient-oriented cardiovascular composite endpoint and stent thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRE8 group | Experimental | Device: CRE8 sirolimus-eluting stentCRE8 sirolimus-eluting stent system |
| RESOLUTE group | Active comparator | Device: RESOLUTE zotarolimus-eluting stentRESOLUTE zotarolimus-eluting stent system |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 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 (lesions number ≤ 2);
- Target vessel diameter between 2.25 and 4.0 mm and target lesion length ≤ 27mm by visual estimation;
- Target lesion diameter stenosis ≥ 70% by visual estimation;
Key exclusion criteria (13 listed)
- Patients with acute myocardial infarction (AMI) within one week;
- Chronic total occlusion lesion (TIMI flow 0 before procedure), Left main disease and/or triple-vessel lesion that might require treatment, bifurcation lesions with a side branch diameter >2.5mm or graft lesions;
- 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 lesion;
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 is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium alloy and is coated with i-carbofilm.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 |
| RESOLUTE zotarolimus-eluting stentThe RESOLUTE stent is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium tungsten alloy. It has been approved by CFDA in 2009 and commercially available in Chinese market | Device | RESOLUTE group |
Primary outcome
In-stent late lumen loss (LLL)
Time frame: 9months after the procedure
7 secondary outcomes
In-stent, proximal stent edge, distal stent edge and In-segment binary restenosis rate
Time frame: 9months after the procedure
In-segment late lumen loss (LLL)
Time frame: 9months after the procedure
Target lesion failure (TLF) rate
Time frame: 1month, 6months, 9months, 12months and annually up to 5 years follow-up
Number of participants with stent thrombosis per ARC definition
Time frame: 1month, 6months, 9months, 12months and annually up to 5 years follow-up
The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations
Time frame: 1month, 6months, 9months, 12months and annually up to 5 years follow-up
device and lesion success rates
Time frame: immediately 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?
A Phase 3 study testing CRE8 sirolimus-eluting stent and RESOLUTE zotarolimus-eluting stent in people with 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 17 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
In-stent late lumen loss (LLL) (time frame: 9months 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.