Coronary Artery DiseasesNCT01226355
NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System
A study testing stent in people with Coronary Artery Diseases, run by Medfavour (Beijing) Medical Co., Ltd at 1 site in China.
Trial summary
A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Diseases
- What is being tested?
- stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to Nov 2014
- Phase
- Interventional
- 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 18-75 years, men or unpregnant women;
- Angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;
- Total of lesion artery ≤2;
- Lesion artery ≤30 mm in length, 2.25 to 4.0 mm in diameter (ocular estimate);
- Narrow level of lesion artery ≥70% in diameter (ocular estimate);
- Amount of same stents implanted in a lesion artery ≤2;
- Patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique);
- Patients knowing about the objective of trial, willing to sign a statement of informed consent and join in this trial, and willing to accept follow-up.
Who cannot join
- Patients with acute myocardial infarction in 7 days;
- Chronic total occlusion lesions(TIMI 0 grade blood flow prior to implantation), left trunk vessel lesion, three-branch lesions needing treated, fork and bridge vessel lesions of branch vessels whose diameter ≥2.25mm;
- Severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;
- In-stent restenosis lesions;
- Patients with stent implantation in his/her coronary artery within recent one year;
- Severs heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)< 40%( supersonic inspection or left ventricular radiography );
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- Kidney functional damage prior to implantation, serum creatinine level>2.0mg/dl;
- Patients with hemorrhage tendency, an active digestive ulcer history, a cerebral hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a year, and these patients who contraindicate against platelet inhibitors and anticoagulant therefore can not bear anticoagulation treatment;
- Patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals;
- Patients whose life expectancy less than 12 months;
- Patients who are participating in other drugs or medical devices clinical trials;
- Patients who can not comply with the clinical trial protocol;
- Patients having a heart transplant.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases
Beijing, 100037
About this study
Official title: Clinical Trial Program of a Medical Instrument Product
A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.
Read the detailed description
A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions. Appropriate patients judged by inclusion and exclusion standards will be preformed stent implantation, and after that all patients will be clinically followed up at 30, 90, 180, 270,365 days,2 years,3 years,4 years and 5 years. Especially, standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents. Major adverse cardiac events (MACEs) found in following-up period as key indicators to evaluate the safety of stents. The arrangement, conclusion and statistical analysis of trial data including clinography and angiography will be fulfilled by independent Data Management Center(DMC) and radiography core laboratory.
- Conditions
- Coronary Artery Diseases
- Being tested
- 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.
stentDevice
Also called NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System, Firebird2 drug-eluting stents
NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System is manufactured by Medfavour (Beijing) Medical Co., Ltd.
Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| NOYA | Experimental | implant NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stents Intervention: Device: stent Receives: Device: stent |
| Firebird2 | Active comparator | implant Firebird2 drug-eluting stents Intervention: Device: stent Receives: Device: stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent late loss at 9-month
Standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents.
Measured: 270 days (±30days)
Secondary outcomes (1)
MACEs found in follow-up period
Major adverse cardiac events (MACEs) found in following-up period as key indicators to evaluate the safety of stents.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medfavour (Beijing) Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Division of Biometrics,National Center for Cardiovascular Diseases,China
- Responsible party
- Sponsor
- Investigators
- Runlin Gao, Professor, Principal investigator, Fu Wai Hospital, National Center for Cardiovascular Diseases,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226355
- Sponsor's protocol ID
- FW2009-183
- Status last verified
- May 2012
- First submitted
- 21 Oct 2010
- Last updated
- 22 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu B, Dou K, Yang Y, Lv S, Wang L, Wang H, Li Z, Wang L, Chen Y, Huo Y, Li W, Kirtane AJ, Gao R. Nine-month angiographic and 2-year clinical follow-up of the NOYA biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the NOYA I trial. EuroIntervention. 2012 Nov 22;8(7):796-802. doi: 10.4244/EIJV8I7A122.
PubMed 23171800
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Program of a Medical Instrument Product
- ClinicalTrials.gov ID
- NCT01226355
- Acronym / sponsor ID
- FW2009-183
- Conditions
- Coronary Artery Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Medfavour (Beijing) Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Division of Biometrics,National Center for Cardiovascular Diseases,China
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Nov 2014 (estimated)
- First posted
- 22 Oct 2010 (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.
A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.
Detailed description
A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions. Appropriate patients judged by inclusion and exclusion standards will be preformed stent implantation, and after that all patients will be clinically followed up at 30, 90, 180, 270,365 days,2 years,3 years,4 years and 5 years. Especially, standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents. Major adverse cardiac events (MACEs) found in following-up period as key indicators to evaluate the safety of stents. The arrangement, conclusion and statistical analysis of trial data including clinography and angiography will be fulfilled by independent Data Management Center(DMC) and radiography core laboratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOYA | Experimental | Device: stentimplant NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stents Intervention: Device: stent |
| Firebird2 | Active comparator | Device: stentimplant Firebird2 drug-eluting stents Intervention: Device: stent |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years, men or unpregnant women;
- Angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;
- Total of lesion artery ≤2;
- Lesion artery ≤30 mm in length, 2.25 to 4.0 mm in diameter (ocular estimate);
- Narrow level of lesion artery ≥70% in diameter (ocular estimate);
Key exclusion criteria (13 listed)
- Patients with acute myocardial infarction in 7 days;
- Chronic total occlusion lesions(TIMI 0 grade blood flow prior to implantation), left trunk vessel lesion, three-branch lesions needing treated, fork and bridge vessel lesions of branch vessels whose diameter ≥2.25mm;
- Severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;
- In-stent restenosis lesions;
- Patients with stent implantation in his/her coronary artery within recent one year;
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 |
|---|---|---|
| stentAlso: NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System, Firebird2 drug-eluting stentsNOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System is manufactured by Medfavour (Beijing) Medical Co., Ltd. Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. | Device | Firebird2, NOYA |
Primary outcome
In-stent late loss at 9-month
Time frame: 270 days (±30days)
Standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents.
1 secondary outcome
MACEs found in follow-up period
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2012.
- Derived from this study: PubMed 23171800Xu B, Dou K, Yang Y, Lv S, Wang L, Wang H, Li Z, Wang L, Chen Y, Huo Y, Li W, Kirtane AJ, Gao R. Nine-month angiographic and 2-year clinical follow-up of the NOYA biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the NOYA I trial. EuroIntervention. 2012 Nov 22;8(7):796-802. doi: 10.4244/EIJV8I7A122.
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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.
Runlin Gao, Professor principal investigator
Fu Wai Hospital, National Center for Cardiovascular Diseases,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stent in people with Coronary Artery Diseases, run by Medfavour (Beijing) Medical Co., Ltd 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 8 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 22 May 2012. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent late loss at 9-month (time frame: 270 days (±30days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01226355, which also lists 1 linked publication.
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 22 May 2012.