Coronary Heart DiseaseNCT01752582
BuMA OCT Study(A Comparative Evaluation of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)
A study testing BuMA stent and EXCEL stent in people with Coronary Heart Disease and Stable Angina Pectoris, run by Sino Medical Sciences Technology Inc. at 1 site in China.
Trial summary
The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in terms of the extent of neointima formation at 3 months after implantation using OCT. This is a prospective, single center, randomized, open-label, non-inferiority study, which will enroll a total of 70 patients in Fuwai… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Heart Disease, Stable Angina Pectoris, Unstable Angina Pectoris
- What is being tested?
- BuMA stent and EXCEL stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 85 years.
- Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study).
- The patient has a planned intervention of up to four de novo lesions, in different epicardial vessels.
- Lesion(s) must have a visually estimated diameter stenosis of ≥50% and <100%.
- Reference Vessel Diameter(RVD) must be between 2.5-4.0 mm
- Written informed consent.
- The patient and the patient's physician agree to the follow-up visits including angiographic follow-up and OCT controls at 3 months.
Who cannot join
- Evidence of ongoing acute myocardial infarction in ECG prior to procedure.
- Left ventricular ejection fraction(LVEF) <30%.
- Documented or suspected liver disease (including laboratory evidence of hepatitis).
- Known renal insufficiency (e.g. estimated glomerular filtration rate(eGFR) <60 ml/kg/m2 or serum creatinine level of >2.5 mg/dL, or subject on dialysis).
- History of bleeding diathesis or coagulopathy.
- The patient is a recipient of a heart transplant.
Show all 12Show fewer
- Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and ticlopidine), sirolimus or stainless steel.
- Other medical illness (e.g. cancer, neurological deficiency) or known history of substance abuse (alcohol etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.
- Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- OCT exclusion criteria
- Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
- Total occlusion or thrombolysis in myocardial infarction(TIMI) flow 0, prior to wire crossing.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100037
About this study
Official title: BuMA OCT Study(A Comparative Evaluation of BuMA Stent and of EXCEL Stent in Terms of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)
The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in terms of the extent of neointima formation at 3 months after implantation using OCT.
This is a prospective, single center, randomized, open-label, non-inferiority study, which will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority was met, superiority test will be planned.
Read the detailed description
About 70 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Fuwai Hospital,will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio).
All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months (including angiographic/OCT investigation), 6 months, 1 and 2 years post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.
- Conditions
- Coronary Heart Disease, Stable Angina Pectoris, Unstable Angina Pectoris, Silent Myocardial Ischemia
- Being tested
- BuMA stent, EXCEL stent
- Keywords
- BuMA, EXCEL, OCT, stent, neointima formation
- Medical subject headings
- Coronary Disease, Angina, Stable, Angina, Unstable, Neointima
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuMA stentDevice
About 35 patients will undergoing implantation of BuMA stent and receive 6 months dual antiplatelet therapy.
EXCEL stentDevice
About 35 patients will undergoing implantation of EXCEL stent and receive 6 months dual antiplatelet therapy.
| Study group | Role | What they receive |
|---|---|---|
| BuMA stent | Other | This study will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned two groups(in a 1:1 ratio).
BuMA stent Arm:About 35 patients will undergoing implantation of BuMA stent.All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months(including angiographic/OCT investigation), 6 months, 1 and 2 years post PCI,in order to observe the Primary Endpoint and Secondary Endpoints. Receives: Device: BuMA stent |
| EXCEL stent | Other | This study will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned two groups(in a 1:1 ratio).
EXCEL stent Arm:About 35 patients will undergoing implantation of EXCEL stent.All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months(including angiographic/OCT investigation), 6 months, 1 and 2 years post PCI,in order to observe the Primary Endpoint and Secondary Endpoints. Receives: Device: EXCEL stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.
The primary outcome measure is the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.
Measured: three months after surgery
Secondary outcomes (17)
Neointimal hyperplasia area/volume
It will be measure the neointimal hyperplasia area/volume at 3 months follow-up by OCT assessment.
Measured: three months after surgery
Mean/Minimal Stent diameter/area/volume
It will be measure the Mean/Minimal stent diameter/area/volume at 3 months follow-up by OCT assessment.
Measured: three months after surgery
Mean/Minimal Lumen diameter/area/volume
It will be measure the Mean/Minimal Lumen diameter/area/volume at 3 months follow-up by OCT assessment.
Measured: three months after surgery
Mean/maximal thickness of the struts coverage
It will be measure the Mean/maximal thickness of the struts coverage at 3 months follow-up by OCT assessment.
Measured: three months after surgery
Incomplete strut apposition
It will be measure the incomplete strut apposition at 3 months follow-up by OCT assessment.
Measured: three months after surgery
Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months
Measured: three months after surgery
Late Lumen Loss at 3 months
Measured: three months after surgery
Binary Restenosis (DS ≥50%) at 3 months
All measurements will be made of the in-stent, in-segment, proximal and distal stent margins.
Measured: three months after surgery
Acute success rate
It includes the device success,lesion success and procedural success.
Measured: up to 7 days after surgery
Device-oriented Composite Endpoints and its individual components at 3 months
Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, Myocardial Infarction(MI) not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
Measured: three months after surgery
Device-oriented Composite Endpoints and its individual components at 6 months
Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
Measured: six months after surgery
Device-oriented Composite Endpoints and its individual components at 1 year
Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
Measured: one year after surgery
Device-oriented Composite Endpoints and its individual components at 2 years
Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
Measured: 2 years after surgery
Stent thrombosis according to the ARC definitions at 3 months
Measured: three months after surgery
Stent thrombosis according to the ARC definitions at 6 months
Measured: six months after surgery
Stent thrombosis according to the ARC definitions at 1 year
Measured: one year after surgery
Stent thrombosis according to the ARC definitions at 2 years
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sino Medical Sciences Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yang Y Jin, president, Principal investigator, Fuwai Hospital, Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752582
- Sponsor's protocol ID
- version1.1
- Status last verified
- Mar 2016
- First submitted
- 7 Dec 2012
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BuMA OCT Study(A Comparative Evaluation of BuMA Stent and of EXCEL Stent in Terms of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)
- ClinicalTrials.gov ID
- NCT01752582
- Acronym / sponsor ID
- version1.1
- Conditions
- Coronary Heart Disease, Stable Angina Pectoris, Unstable Angina Pectoris, Silent Myocardial Ischemia
- Keywords
- BuMA, EXCEL, OCT, stent, neointima formation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sino Medical Sciences Technology Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- First posted
- 19 Dec 2012 (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 objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in terms of the extent of neointima formation at 3 months after implantation using OCT.
This is a prospective, single center, randomized, open-label, non-inferiority study, which will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority was met, superiority test will be planned.
Detailed description
About 70 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Fuwai Hospital,will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio).
All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months (including angiographic/OCT investigation), 6 months, 1 and 2 years post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BuMA stent | Other | Device: BuMA stentThis study will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned two groups(in a 1:1 ratio). BuMA stent Arm:About 35 patients will undergoing implantation of BuMA stent.All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months(including angiographic/OCT investigation), 6 months, 1 and 2 years post PCI,in order to observe the Primary Endpoint and Secondary Endpoints. |
| EXCEL stent | Other | Device: EXCEL stentThis study will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned two groups(in a 1:1 ratio). EXCEL stent Arm:About 35 patients will undergoing implantation of EXCEL stent.All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months(including angiographic/OCT investigation), 6 months, 1 and 2 years post PCI,in order to observe the Primary Endpoint and Secondary Endpoints. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 85 years.
- Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study).
- The patient has a planned intervention of up to four de novo lesions, in different epicardial vessels.
- Lesion(s) must have a visually estimated diameter stenosis of ≥50% and <100%.
- Reference Vessel Diameter(RVD) must be between 2.5-4.0 mm
Key exclusion criteria (12 listed)
- Evidence of ongoing acute myocardial infarction in ECG prior to procedure.
- Left ventricular ejection fraction(LVEF) <30%.
- Documented or suspected liver disease (including laboratory evidence of hepatitis).
- Known renal insufficiency (e.g. estimated glomerular filtration rate(eGFR) <60 ml/kg/m2 or serum creatinine level of >2.5 mg/dL, or subject on dialysis).
- History of bleeding diathesis or coagulopathy.
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 |
|---|---|---|
| BuMA stentAbout 35 patients will undergoing implantation of BuMA stent and receive 6 months dual antiplatelet therapy. | Device | BuMA stent |
| EXCEL stentAbout 35 patients will undergoing implantation of EXCEL stent and receive 6 months dual antiplatelet therapy. | Device | EXCEL stent |
Primary outcome
the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.
Time frame: three months after surgery
The primary outcome measure is the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.
17 secondary outcomes
Neointimal hyperplasia area/volume
Time frame: three months after surgery
Mean/Minimal Stent diameter/area/volume
Time frame: three months after surgery
Mean/Minimal Lumen diameter/area/volume
Time frame: three months after surgery
Mean/maximal thickness of the struts coverage
Time frame: three months after surgery
Incomplete strut apposition
Time frame: three months after surgery
Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months
Time frame: three months after surgery
Late Lumen Loss at 3 months
Time frame: three months after surgery
Binary Restenosis (DS ≥50%) at 3 months
Time frame: three months after surgery
Acute success rate
Time frame: up to 7 days after surgery
Device-oriented Composite Endpoints and its individual components at 3 months
Time frame: three months after surgery
Device-oriented Composite Endpoints and its individual components at 6 months
Time frame: six months after surgery
Device-oriented Composite Endpoints and its individual components at 1 year
Time frame: one year after surgery
Device-oriented Composite Endpoints and its individual components at 2 years
Time frame: 2 years after surgery
Stent thrombosis according to the ARC definitions at 3 months
Time frame: three months after surgery
Stent thrombosis according to the ARC definitions at 6 months
Time frame: six months after surgery
Stent thrombosis according to the ARC definitions at 1 year
Time frame: one year after surgery
Stent thrombosis according to the ARC definitions at 2 years
Time frame: 2 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
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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.
Yang Y Jin, president principal investigator
Fuwai Hospital, Chinese Academy of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BuMA stent and EXCEL stent in people with Coronary Heart Disease and Stable Angina Pectoris, run by Sino Medical Sciences Technology Inc. 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 14 Mar 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment. (time frame: three months after surgery). 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 14 Mar 2016.