Coronary Artery DiseaseNCT01024179
Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns
A study testing Polymer-based sirolimus-eluting stent (Partner stent ) in people with Coronary Artery Disease, run by Harbin Medical University at 1 site in China.
Trial summary
Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent risk factor for most of acute cardiac event. Current clinical data showed that thin-cap fibroatheroma was more frequently observed in patients with ACS than SAP. 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?
- Polymer-based sirolimus-eluting stent (Partner stent )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Dec 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
- General Inclusion Criteria：
- Age:18-75Y
- Patients with stable angina or acute coronary syndrome considered suitable for coronary revascularization.
- Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent.
- Angiographic Inclusion Criteria：
- Significant coronary de novo lesion (> 70% by visual estimation).
- Target lesion is de novo native coronary artery lesion that can be treated with 1-2 stents.
- Reference vessel diameter of 2.5 to 4.0 mm.
Who cannot join
- General Exclusion Criteria：
- ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
- Previous CABG.
- Life expectancy <12 months due to another medical condition.
- Contraindication to antiplatelet therapy
- Creatinine level more than 2.0mg/dL or ESRD.
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- Severe hepatic dysfunction (more than 3 times normal reference values).
- Planned surgery procedure ≤ 6 months post-index procedure.
- Known allergy to stainless steel or a history of hypersensitivity to sirolimus or structurally related compounds.
- Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure.
- Patient is not clinically appropriate for OCT evaluation in the opinion of the investigator.
- Angiographic Exclusion Criteria：
- Study lesion is ostial in location (within 3.0 mm of vessel origin).
- Study lesion involving arterial segments with highly tortuous anatomy.
- Complex lesion morphologies (aorto-ostial, bifurcation needs two stents technique, left main, severe thrombi, heavy calcification).
Trial locations and contacts
1 site in 1 country.
China1 site
The second Affiliated Hospital of Harbin Medical University
Harbin, Heilong Jiang, 150081
About this study
Official title: Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns After Sirolimus-eluting Stent Implantation Assessment by Optical Coherence Tomography
Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent risk factor for most of acute cardiac event. Current clinical data showed that thin-cap fibroatheroma was more frequently observed in patients with ACS than SAP. Further OCT study indicated that patients with ACS had significantly higher incidence of incomplete neointimal coverage and malapposition after DES implantation than those with SAP. These findings imply that initial native lesion characteristics may be related to different vessel response (neointimal coverage and malapposition) after stenting. However, there is little data on the relationship between plaque characteristics and vascular response to DES after stent implantation evaluated by OCT.
Therefore, this study was designed to investigate the relationship between initial plaque characteristics and stent surface coverage or late malapposition after SES implantation. The investigators will use high resolution OCT to assess the initial culprit plaque morphology and subsequent vascular response after SES stenting at the time points of post-stenting, 6 months and 12 months. IVUS will also be performed to evaluate the tissue protrusion, malapposition, vessel remodeling at the same time points.
Read the detailed description
Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent risk factor for most of acute cardiac event. Current clinical data showed that thin-cap fibroatheroma was more frequently observed in patients with ACS than SAP. Further OCT study indicated that patients with ACS had significantly higher incidence of incomplete neointimal coverage and malapposition after DES implantation than those with SAP. These findings imply that initial native lesion characteristics may be related to different vessel response (neointimal coverage and malapposition) after stenting. However, there is little data on the relationship between plaque characteristics and vascular response to DES after stent implantation evaluated by OCT.
Therefore, this study was designed to investigate the relationship between initial plaque characteristics and stent surface coverage or late malapposition after SES implantation. The investigators will use high resolution OCT to assess the initial culprit plaque morphology and subsequent vascular response after SES stenting at the time points of post-stenting, 6 months and 12 months.
- Conditions
- Coronary Artery Disease
- Being tested
- Polymer-based sirolimus-eluting stent (Partner stent )
- Keywords
- Optical Coherence Tomography, Coronary artery disease, Chronic total occlusion
- 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.
Polymer-based sirolimus-eluting stent (Partner stent )Device
Partner stent (polymer-based sirolimus-eluting stent) implanted in culprit coronary artery
| Study group | Role | What they receive |
|---|---|---|
| Group B: CTO | Active comparator | Chronic total occlusion Receives: Device: Polymer-based sirolimus-eluting stent (Partner stent ) |
| Group A : Non-CTO | Active comparator | Non-chronic total occlusion :
1. Fibrous plaque+fibro-calcific plaque + Lipid plaque(<2 quadrants )
2. Lipid-rich plaque ( ≥2 quadrants ) Receives: Device: Polymer-based sirolimus-eluting stent (Partner stent ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.
To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.
Measured: 6 months
Secondary outcomes (5)
Relationship between tissue prolapse and initial plaque characteristics
Relationship between tissue prolapse and initial plaque characteristics
Measured: Post-intervention
Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions.
Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions.
Measured: 6-month
Late stent malapposition( by OCT and IVUS ).
Late stent malapposition( by OCT and IVUS ).
Measured: 6 months
Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation.
Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation.
Measured: 12 -month
Comparison of the differences in stent surface coverage between CTO and non- CTO lesions.
Comparison of the differences in stent surface coverage between CTO and non- CTO lesions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Difficulty in enrolling the required number of participants has made it impractical to proceed with the trial.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Bo, Harbin Medical University
- Investigators
- Bo Yu, MD.PhD, Principal investigator, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024179
- Sponsor's protocol ID
- HMUOCT-PLAQUE
- Status last verified
- Nov 2024
- First submitted
- 1 Dec 2009
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns After Sirolimus-eluting Stent Implantation Assessment by Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT01024179
- Acronym / sponsor ID
- HMUOCT-PLAQUE
- Conditions
- Coronary Artery Disease
- Keywords
- Optical Coherence Tomography, Coronary artery disease, Chronic total occlusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling the required number of participants has made it impractical to proceed with the trial.
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- Dec 2009 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Dec 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.
Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent risk factor for most of acute cardiac event. Current clinical data showed that thin-cap fibroatheroma was more frequently observed in patients with ACS than SAP. Further OCT study indicated that patients with ACS had significantly higher incidence of incomplete neointimal coverage and malapposition after DES implantation than those with SAP. These findings imply that initial native lesion characteristics may be related to different vessel response (neointimal coverage and malapposition) after stenting. However, there is little data on the relationship between plaque characteristics and vascular response to DES after stent implantation evaluated by OCT.
Therefore, this study was designed to investigate the relationship between initial plaque characteristics and stent surface coverage or late malapposition after SES implantation. The investigators will use high resolution OCT to assess the initial culprit plaque morphology and subsequent vascular response after SES stenting at the time points of post-stenting, 6 months and 12 months. IVUS will also be performed to evaluate the tissue protrusion, malapposition, vessel remodeling at the same time points.
Detailed description
Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent risk factor for most of acute cardiac event. Current clinical data showed that thin-cap fibroatheroma was more frequently observed in patients with ACS than SAP. Further OCT study indicated that patients with ACS had significantly higher incidence of incomplete neointimal coverage and malapposition after DES implantation than those with SAP. These findings imply that initial native lesion characteristics may be related to different vessel response (neointimal coverage and malapposition) after stenting. However, there is little data on the relationship between plaque characteristics and vascular response to DES after stent implantation evaluated by OCT.
Therefore, this study was designed to investigate the relationship between initial plaque characteristics and stent surface coverage or late malapposition after SES implantation. The investigators will use high resolution OCT to assess the initial culprit plaque morphology and subsequent vascular response after SES stenting at the time points of post-stenting, 6 months and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B: CTO | Active comparator | Device: Polymer-based sirolimus-eluting stent (Partner stent )Chronic total occlusion |
| Group A : Non-CTO | Active comparator | Device: Polymer-based sirolimus-eluting stent (Partner stent )Non-chronic total occlusion : 1. Fibrous plaque+fibro-calcific plaque + Lipid plaque(<2 quadrants ) 2. Lipid-rich plaque ( ≥2 quadrants ) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- General Inclusion Criteria：
- Age:18-75Y
- Patients with stable angina or acute coronary syndrome considered suitable for coronary revascularization.
- Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent.
- Angiographic Inclusion Criteria：
Key exclusion criteria (15 listed)
- General Exclusion Criteria：
- ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
- Previous CABG.
- Life expectancy <12 months due to another medical condition.
- Contraindication to antiplatelet therapy
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 |
|---|---|---|
| Polymer-based sirolimus-eluting stent (Partner stent )Partner stent (polymer-based sirolimus-eluting stent) implanted in culprit coronary artery | Device | Group A : Non-CTO, Group B: CTO |
Primary outcome
To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.
Time frame: 6 months
To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.
5 secondary outcomes
Relationship between tissue prolapse and initial plaque characteristics
Time frame: Post-intervention
Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions.
Time frame: 6-month
Late stent malapposition( by OCT and IVUS ).
Time frame: 6 months
Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation.
Time frame: 12 -month
Comparison of the differences in stent surface coverage between CTO and non- CTO lesions.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Difficulty in enrolling the required number of participants has made it impractical to proceed with the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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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.
Bo Yu, MD.PhD principal investigator
The Second Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymer-based sirolimus-eluting stent (Partner stent ) in people with Coronary Artery Disease, run by Harbin Medical University 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 15 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: stopped early, as of the sponsor's last update on 2 Dec 2024. 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 was stopped early (reason given: Difficulty in enrolling the required number of participants has made it impractical to proceed with the trial.). 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?
To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation. (time frame: 6 months). 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 2 Dec 2024.