Coronary Bifurcation LesionsNCT03172845
Optical Coherence Tomography (OCT) Findings and Coronary Bifurcation Lesions
A study testing percutaneous coronary intervention in people with Coronary Bifurcation Lesions, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
To determine the clinical prevalence of vulnerable plaque using OCT in patients with coronary bifurcation lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Bifurcation Lesions
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2017to 30 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old
- Patients with ischemic heart disease who are considered for coronary revascularization with PCI
- True coronary bifurcation lesion Medina 1.1.1, 0.1.1, 1.0.1 (stenosis> 50% by visual estimation) treated by drug-eluting stent
- Reference vessel diameter of main vessel >= 2.5mm and side branch >=2.0 mm by visual estimation
Who cannot join
- Saphenous vein grafts
- In-stent restenotic lesions
- Thombus-containing lesions
- Patient who had Myocardial infarction with in less than one month
- Patent who had bifurcation lesion dilation with balloon
- Contraindication or hypersensitivity to anti-platelet agents or contrast media
Show all 12Show fewer
- Creatinine level ≥ 2.0 mg/dL
- Severe hepatic dysfunction (3 times normal reference values)
- Hemodynamic unstable patients
- Inability of OCT devise to cross the lesion into distal vessel
- Pregnant women or women with potential childbearing
- Inability to understand or read the informed content
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Vulnerable Plaque Its Location and Clinical Significance in Bifurcation Lesions Detected by Optical Coherence Tomography.
To determine the clinical prevalence of vulnerable plaque using OCT in patients with coronary bifurcation lesion.
Read the detailed description
This is a prospective registry study in which patient with bifurcation lesion undergoing baseline coronary angiography, baseline OCT and percutaneous coronary intervention will be studied. OCT is used to assess the prevalence of vulnerable plaque, its location at bifurcation lesions and compare vulnerable plaque related major adverse cardiovascular events (MACE) during one-year follow-up in bifurcation lesions between patients with vulnerable plaque and those without. Relationship between endothelial shear stress and vulnerable plaque. Relationship between bifurcation angle and vulnerable plaque.
Group A: presence of vulnerable plaque at the bifurcation Group B: absence of vulnerable plaque at the bifurcation Documentation of immediate post stent OCT and 12 months follow up angiography with OCT will be performed. Immediate post stent OCT to assess successful stent implantation and after 12 months follow up to document year major adverse cardiovascular events (MACE) included myocardial infraction, cardiac death and clinically driven target lesion revascularization, stent thrombosis.
- Conditions
- Coronary Bifurcation Lesions
- Being tested
- percutaneous coronary intervention
- Keywords
- coronary bifurcation lesion, optical coherence tomography, vulnerable plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
Also called PCI
percutaneous coronary intervention with drug-eluting stent implantation.
| Study group | Role | What they receive |
|---|---|---|
| Vulnerable plaque | Experimental | Thin-cap fibro atheroma (TCFA) was defined as a lipid-rich plaque with the thinnest fibrous cap thickness<65um. Plaque rupture was identified by the presence of fibrous cap discontinuity with a clear cavity formation inside the plaque. Plaque erosion is characterized by luminal thrombus and absence of the endothelium or without evidence of fibrous cap disruption. Fibro calcific plaque contains OCT evidence of fibrous tissue along with calcium that appears as a signal-poor or heterogeneous region with a sharply delineated border which is applied to larger calcifications. Calcified nodule is characterized as a signal or multiple regions of calcium protruding into the lumen, superficial calcification accompanied by substantive calcium proximal and or distal to the lesion. Thrombus is defined as a mass attached to luminal surface or floating within the lumen. It is seen as a protrusion inside the lumen of the artery with signal attenuation. Receives: Procedure: percutaneous coronary intervention |
| Without any vulnerable plaqueStable plaque | Active comparator | patient with bifurcation lesion undergoing baseline coronary angiography and baseline OCT. Receives: Procedure: percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of coronary vulnerable plaques in bifurcation lesions using coherence tomography (OCT)
Vulnerable plaque was considered when presence of Thin-cap fibro atheroma (TCFA), Lipid-rich plaque (vulnerable), Plaque rupture, Plaque erosion, thrombus and calcified nodule.
Measured: Documentation of baseline OCT
Secondary outcomes (7)
Major Adverse Cardiovascular Events (MACE)
MACE was included myocardial infarction, cardiac death, and target lesion revascularization.
Measured: 0 to 12 months
Stent Thrombosis
Stent thrombosis was defined according to the Academic Research Consortium definition.
Measured: 0 to 12 months
Thin-cap fibroatheroma
Thin-cap fibroatheroma was defined as a lipid-rich plaque with the thinnest fibrous cap thickness < 65 µm.
Measured: 0 to 12 months
Calcified nodule
Calcified nodule is characterized as a signal or multiple regions of calcium protruding into the lumen, superficial calcification accompanied by substantive calcium proximal and or distal to the lesion.
Measured: 0 to 12 months
Plaque erosion
Plaque erosion is characterized by luminal thrombus and absence of the endothelium, without evidence of fibrous cap disruption.
Measured: 0 to 12 months
Plaque rupture
Rupture was identified by the presence of fibrous cap discontinuity with a clear cavity formation inside the plaque.
Measured: 0 to 12 months
Thrombus
Thrombus is defined as a mass attached to luminal surface or floating within the lumen. It is seen as a protrusion inside the lumen of the artery with signal attenuation.
Measured: 0 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start27 Jun 2017
- Primary completion30 Jun 2018
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bifurcation LesionsStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shaoliang Chen, MD, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172845
- Sponsor's protocol ID
- NFH20170423
- Status last verified
- Jul 2019
- First submitted
- 11 May 2017
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Vulnerable Plaque Its Location and Clinical Significance in Bifurcation Lesions Detected by Optical Coherence Tomography.
- ClinicalTrials.gov ID
- NCT03172845
- Acronym / sponsor ID
- NFH20170423
- Conditions
- Coronary Bifurcation Lesions
- Keywords
- coronary bifurcation lesion, optical coherence tomography, vulnerable plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 1 Jun 2017 (actual)
- 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.
To determine the clinical prevalence of vulnerable plaque using OCT in patients with coronary bifurcation lesion.
Detailed description
This is a prospective registry study in which patient with bifurcation lesion undergoing baseline coronary angiography, baseline OCT and percutaneous coronary intervention will be studied. OCT is used to assess the prevalence of vulnerable plaque, its location at bifurcation lesions and compare vulnerable plaque related major adverse cardiovascular events (MACE) during one-year follow-up in bifurcation lesions between patients with vulnerable plaque and those without. Relationship between endothelial shear stress and vulnerable plaque. Relationship between bifurcation angle and vulnerable plaque.
Group A: presence of vulnerable plaque at the bifurcation Group B: absence of vulnerable plaque at the bifurcation Documentation of immediate post stent OCT and 12 months follow up angiography with OCT will be performed. Immediate post stent OCT to assess successful stent implantation and after 12 months follow up to document year major adverse cardiovascular events (MACE) included myocardial infraction, cardiac death and clinically driven target lesion revascularization, stent thrombosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vulnerable plaque | Experimental | Procedure: percutaneous coronary interventionThin-cap fibro atheroma (TCFA) was defined as a lipid-rich plaque with the thinnest fibrous cap thickness<65um. Plaque rupture was identified by the presence of fibrous cap discontinuity with a clear cavity formation inside the plaque. Plaque erosion is characterized by luminal thrombus and absence of the endothelium or without evidence of fibrous cap disruption. Fibro calcific plaque contains OCT evidence of fibrous tissue along with calcium that appears as a signal-poor or heterogeneous region with a sharply delineated border which is applied to larger calcifications. Calcified nodule is characterized as a signal or multiple regions of calcium protruding into the lumen, superficial calcification accompanied by substantive calcium proximal and or distal to the lesion. Thrombus is defined as a mass attached to luminal surface or floating within the lumen. It is seen as a protrusion inside the lumen of the artery with signal attenuation. |
| Without any vulnerable plaqueStable plaque | Active comparator | Procedure: percutaneous coronary interventionpatient with bifurcation lesion undergoing baseline coronary angiography and baseline OCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 18 years old
- Patients with ischemic heart disease who are considered for coronary revascularization with PCI
- True coronary bifurcation lesion Medina 1.1.1, 0.1.1, 1.0.1 (stenosis> 50% by visual estimation) treated by drug-eluting stent
- Reference vessel diameter of main vessel >= 2.5mm and side branch >=2.0 mm by visual estimation
Key exclusion criteria (12 listed)
- Saphenous vein grafts
- In-stent restenotic lesions
- Thombus-containing lesions
- Patient who had Myocardial infarction with in less than one month
- Patent who had bifurcation lesion dilation with balloon
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 |
|---|---|---|
| percutaneous coronary interventionAlso: PCIpercutaneous coronary intervention with drug-eluting stent implantation. | Procedure or surgery | Vulnerable plaque, Without any vulnerable plaqueStable plaque |
Primary outcome
The prevalence of coronary vulnerable plaques in bifurcation lesions using coherence tomography (OCT)
Time frame: Documentation of baseline OCT
Vulnerable plaque was considered when presence of Thin-cap fibro atheroma (TCFA), Lipid-rich plaque (vulnerable), Plaque rupture, Plaque erosion, thrombus and calcified nodule.
7 secondary outcomes
Major Adverse Cardiovascular Events (MACE)
Time frame: 0 to 12 months
Stent Thrombosis
Time frame: 0 to 12 months
Thin-cap fibroatheroma
Time frame: 0 to 12 months
Calcified nodule
Time frame: 0 to 12 months
Plaque erosion
Time frame: 0 to 12 months
Plaque rupture
Time frame: 0 to 12 months
Thrombus
Time frame: 0 to 12 months
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 30 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Shaoliang Chen, MD study chair
Nanjing First Hospital, Nanjing 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 percutaneous coronary intervention in people with Coronary Bifurcation Lesions, run by Nanjing First Hospital, Nanjing 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 4 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 30 Jul 2019. 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 prevalence of coronary vulnerable plaques in bifurcation lesions using coherence tomography (OCT) (time frame: Documentation of baseline OCT). 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 Jul 2019.