Coronary DiseaseProstentNCT00887211
ProStent Coronary Drug-Eluting Stent
A study testing stent in people with Coronary Disease, run by CCRF Consulting Co., Ltd. at 1 site in China.
Trial summary
A single blind, multi-center, randomized study is preformed to compare ProStent drug-eluting stents with Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of ProStent drug-eluting stent in treating coronary artery lesions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Mar 2010
- 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, 2.5 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 fellow-up
Who cannot join
- Patients with acute myocardial infarction in recent one month;
- 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 ≥2.5mm;
- 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, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, 100037
Runlin Gao, gaorunlin@263.net
About this study
Official title: Clinical Trial Program of a Medical Instrument Product
A single blind, multi-center, randomized study is preformed to compare ProStent drug-eluting stents with Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of ProStent drug-eluting stent in treating coronary artery lesions.
Read the detailed description
A single blind, multi-center, randomized study is preformed to compare ProStent drug-eluting stents with Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of ProStent drug-eluting stent 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 and 365 days. 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 Disease
- Being tested
- stent
- Keywords
- stent, coronary artery disease
- Medical subject headings
- Coronary Disease, 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 ProStent rapamycin-eluting stent system
ProStent rapamycin-eluting stent system manufactured by Tianjian Medical Technology (Suzhou) Co., Ltd.
stentDevice
Also called Firebird drug-eluting stents
Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| ProStent | Active comparator | implant ProStent drug-eluting stents Receives: Device: stent |
| Firebird | Active comparator | implant Firebird drug-eluting stents Receives: Device: stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late luminal loss(LLL) detected through quantity coronary angiography (QCA) at 270 days(±30days) follow-up
Measured: 270 days(±30days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startOct 2008
- Primary completionFeb 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCRF Consulting Co., Ltd.
- Sponsor type
- University, hospital or other
- Investigators
- Runlin Gao, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887211
- Sponsor's protocol ID
- Prostent
- Acronym
- Prostent
- Status last verified
- Apr 2009
- First submitted
- 21 Apr 2009
- Last updated
- 30 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2009. 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
- NCT00887211
- Acronym / sponsor ID
- Prostent / Prostent
- Conditions
- Coronary Disease
- Keywords
- stent, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- CCRF Consulting Co., Ltd.University, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 23 Apr 2009 (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 ProStent drug-eluting stents with Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of ProStent drug-eluting stent in treating coronary artery lesions.
Detailed description
A single blind, multi-center, randomized study is preformed to compare ProStent drug-eluting stents with Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of ProStent drug-eluting stent 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 and 365 days. 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 |
|---|---|---|
| ProStent | Active comparator | Device: stentimplant ProStent drug-eluting stents |
| Firebird | Active comparator | Device: stentimplant Firebird drug-eluting stents |
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, 2.5 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 recent one month;
- 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 ≥2.5mm;
- 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: ProStent rapamycin-eluting stent systemProStent rapamycin-eluting stent system manufactured by Tianjian Medical Technology (Suzhou) Co., Ltd. | Device | ProStent |
| stentAlso: Firebird drug-eluting stentsFirebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. | Device | Firebird |
Primary outcome
Late luminal loss(LLL) detected through quantity coronary angiography (QCA) at 270 days(±30days) follow-up
Time frame: 270 days(±30days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2009.
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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 principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
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 Disease, run by CCRF Consulting 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 30 Apr 2009. 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 Xiaohong He (86-10-84094918 ext. 821, danielle_he@ccheart.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late luminal loss(LLL) detected through quantity coronary angiography (QCA) at 270 days(±30days) follow-up (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?
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 30 Apr 2009.