Coronary Artery DiseaseCTCADNCT03195621
Critical Treatment of Coronary Artery Disease
A study testing Stent implantation in people with Coronary Artery Disease and Coronary Artery Disease Progression, run by Southeast University, China at 1 site in China.
Trial summary
Identifying the critical lesion of coronary artery disease and determining the interventional plan are significant for reducing adverse cardiovascular adverse events. The assessment of critical lesion requires the consideration of plaque morphology, tissue composition, and endometrial stress which leading to rupture. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Disease Progression
- What is being tested?
- Stent implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2016to 30 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteered to participate in this study and signed an informed consent form;
- Men or non-pregnant women ≥ 18 and ≤80 years of age;
- Lesion is located in a coronary artery and stenosis is between 50-75%;
Who cannot join
- Severe liver and kidney diseases (GFR<60 ml/min/1.73m2 or CTP≥6 score);
- Moderate to severe hypertension (after standard antihypertensive therapy, blood pressure higher than 160/100mmHg);
- Patients with hemodynamic or electrical instability (including shock);
- Coagulation disorders associated with significant bleeding tendency (eg, hypersensitivity, active bleeding, moderate or severe liver disease, GI bleed within the past 6 months, major surgery within 30 days);
- Patients with ischemic stroke within one week;
- Any contraindication against the use of anti-platelet drugs such as aspirin;
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- Platelet count less than 100 x 109/L, haemoglobin (Hb) level less than 100 g/L;
- Researchers involved in the study and / or immediate family members;
- Participation in another investigation drug or device study in the past 30 days before enrollment;
- Involvement in the planning and conduct of the study (applies to staffs at study sites);
- Suffering from serious arrhythmias include recurrent ventricular tachycardia or ventricular fibrillation;
- Pregnancy or lactation or females of child-bearing potential with the plan of pregnancy in one year;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Strategy for Critical Lesions of Coronary Artery Disease
Identifying the critical lesion of coronary artery disease and determining the interventional plan are significant for reducing adverse cardiovascular adverse events. The assessment of critical lesion requires the consideration of plaque morphology, tissue composition, and endometrial stress which leading to rupture. In summary, accurate assessment of critical lesions has high application value. In this study, patients with critical coronary artery disease were divided into two groups: an accurate assessment group and a simple assessment group, with the aim to compare the diagnosis and treatment efficiency as well as prognosis, potential cardiovascular risk, possible "excessive" intervention.
- Being tested
- Stent implantation
- Keywords
- Coronary Artery Disease, Critical lesion
- 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.
Stent implantationDevice
Stent placement after risk factors assessment plus FFR or ultrasound or OCT detection for critical lesions.
| Study group | Role | What they receive |
|---|---|---|
| Interventional therapy group | Experimental | Not described Receives: Device: Stent implantation |
| Conservative treatment group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular adverse events
Cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis
Measured: one year after enrollment
Secondary outcomes (1)
Chest pain
Frequency of angina pectoris
Measured: one year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Jul 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2019
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Science and Technology Department of Jiangsu Province
- Responsible party
- Principal investigator, Genshan Ma, Southeast University, China
- Investigators
- Gen-shan Ma, Ph.D, Study director, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195621
- Sponsor's protocol ID
- BE2016785
- Acronym
- CTCAD
- Status last verified
- Apr 2023
- First submitted
- 21 Jun 2017
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do not decide whether to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Strategy for Critical Lesions of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03195621
- Acronym / sponsor ID
- CTCAD / BE2016785
- Keywords
- Coronary Artery Disease, Critical lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Science and Technology Department of Jiangsu Province
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 22 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.
Identifying the critical lesion of coronary artery disease and determining the interventional plan are significant for reducing adverse cardiovascular adverse events. The assessment of critical lesion requires the consideration of plaque morphology, tissue composition, and endometrial stress which leading to rupture. In summary, accurate assessment of critical lesions has high application value. In this study, patients with critical coronary artery disease were divided into two groups: an accurate assessment group and a simple assessment group, with the aim to compare the diagnosis and treatment efficiency as well as prognosis, potential cardiovascular risk, possible "excessive" intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups
| Arm | Type | Receives |
|---|---|---|
| Interventional therapy group | Experimental | Device: Stent implantation |
| Conservative treatment group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteered to participate in this study and signed an informed consent form;
- Men or non-pregnant women ≥ 18 and ≤80 years of age;
- Lesion is located in a coronary artery and stenosis is between 50-75%;
Key exclusion criteria (12 listed)
- Severe liver and kidney diseases (GFR<60 ml/min/1.73m2 or CTP≥6 score);
- Moderate to severe hypertension (after standard antihypertensive therapy, blood pressure higher than 160/100mmHg);
- Patients with hemodynamic or electrical instability (including shock);
- Coagulation disorders associated with significant bleeding tendency (eg, hypersensitivity, active bleeding, moderate or severe liver disease, GI bleed within the past 6 months, major surgery within 30 days);
- Patients with ischemic stroke within one week;
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 |
|---|---|---|
| Stent implantationStent placement after risk factors assessment plus FFR or ultrasound or OCT detection for critical lesions. | Device | Interventional therapy group |
Primary outcome
Major cardiovascular adverse events
Time frame: one year after enrollment
Cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis
1 secondary outcome
Chest pain
Time frame: one year after enrollment
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 Apr 2023.
- Individual participant dataSharing planned: Undecided. We do not decide whether to share individual participant data
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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.
Gen-shan Ma, Ph.D study director
Southeast 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 Stent implantation in people with Coronary Artery Disease and Coronary Artery Disease Progression, run by Southeast University, China 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 3 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 Apr 2023. 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?
Major cardiovascular adverse events (time frame: one year after enrollment). 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 Apr 2023.