Cardiovascular DiseasesNCT05548023
Time-trend Analysis of Clinical Characteristic and Outcomes in Patients With Unprotected Left Main Coronary Artery Disease Treated With PCI Over a 10-year Period
A study testing The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent in people with Cardiovascular Diseases, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Surgical coronary bypass surgery (CABG) has been demonstrated to confer significant survival benefit over medical therapies patients with LMCA in earlier clinical trials1,2,3 and therefore was the revascularization modality of choice for a long time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Dec 2023to 7 Feb 2025
- 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
- Lp(a) ≥ 70 mg/dL at the screening visit
- Optimal LDL-cholesterol lowering treatment
- Optimal treatment of other CV risk factors
- Myocardial infarction: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or
- Ischemic stroke: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or
- Clinically significant symptomatic peripheral artery disease
Who cannot join
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count <140,000 per μL
- Active liver disease or hepatic dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Surgical coronary bypass surgery (CABG) has been demonstrated to confer significant survival benefit over medical therapies patients with LMCA in earlier clinical trials1,2,3 and therefore was the revascularization modality of choice for a long time. Recently, several randomized controlled trials and meta-analyses have shown percutaneous coronary intervention (PCI) to be non-inferior to CABG in the treatment of LMCA disease4,5,6,7,8. PCI is now considered to be an appropriate alternative to CABG for LMCA disease in patients with suitable anatomy9,10. Over recent decades, LMCA PCI has been performed in patients with increasing anatomical complexity and higher risk profiles (e.g. elderly, heart failure, renal failure etc). 11,12. In recent years, remarkable advancement in interventional techniques and technologies such as 2nd/3rd generation DES and potent antiplatelet therapy have contributed to the improvement of PCI success rates and reduction in complications and adverse events. Knowledge related to long term temporal variation of clinical and procedural characteristics and outcomes in patients with LMCA disease treated with PCI will therefore be important to inform and define future treatment strategies. This proposal aims to evaluate time-trends and regional differences in clinical characteristics and outcomes of patients with LMCA disease treated with PCI in the Asia-Pacific region
- Conditions
- Cardiovascular Diseases
- Being tested
- The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting StentDevice
The Angiolite stent is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design and a high overexpansion capacity that might overcomes some of these challenges in LMCA PCI. The ANGIOLITE randomized trial confirmed the non-inferiority of the Angiolite stent against the conventional DES
| Study group | Role | What they receive |
|---|---|---|
| unprotected left main coronary artery disease treated with PCI | Other | Not described Receives: Device: The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk reduction of expanded MACE by TQJ230
To demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in 1) the overall study population with established CVD (Lp(a) ≥ 70 mg/dL) and/or 2) in a subpopulation with established CVD and Lp(a) ≥ 90 mg/dL.
Measured: 51 months
Secondary outcomes (2)
MACE reduction by TQJ230
Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the MACE composite of CV death, non-fatal MI and non-fatal stroke.
Measured: 51 months
coronary heart disease (CHD) outcomes by TQJ230
Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, non-fatal MI and urgent coronary re-vascularization requiring hospitalization. Evaluate the rate of all cause death.
Measured: 51 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start8 Dec 2023
- Primary completion8 Dec 2024 (estimated)
- Study completion7 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Bryan Ping Yen YAN, Chinese University of Hong Kong
- Investigators
- Bryan Yan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548023
- Sponsor's protocol ID
- 2023.464
- Status last verified
- Feb 2024
- First submitted
- 16 Sep 2022
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-trend Analysis of Clinical Characteristic and Outcomes in Patients With Unprotected Left Main Coronary Artery Disease Treated With PCI Over a 10-year Period
- ClinicalTrials.gov ID
- NCT05548023
- Acronym / sponsor ID
- 2023.464
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 8 Dec 2024 (estimated)
- Study completion
- 7 Feb 2025 (estimated)
- First posted
- 21 Sep 2022 (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.
Surgical coronary bypass surgery (CABG) has been demonstrated to confer significant survival benefit over medical therapies patients with LMCA in earlier clinical trials1,2,3 and therefore was the revascularization modality of choice for a long time. Recently, several randomized controlled trials and meta-analyses have shown percutaneous coronary intervention (PCI) to be non-inferior to CABG in the treatment of LMCA disease4,5,6,7,8. PCI is now considered to be an appropriate alternative to CABG for LMCA disease in patients with suitable anatomy9,10. Over recent decades, LMCA PCI has been performed in patients with increasing anatomical complexity and higher risk profiles (e.g. elderly, heart failure, renal failure etc). 11,12. In recent years, remarkable advancement in interventional techniques and technologies such as 2nd/3rd generation DES and potent antiplatelet therapy have contributed to the improvement of PCI success rates and reduction in complications and adverse events. Knowledge related to long term temporal variation of clinical and procedural characteristics and outcomes in patients with LMCA disease treated with PCI will therefore be important to inform and define future treatment strategies. This proposal aims to evaluate time-trends and regional differences in clinical characteristics and outcomes of patients with LMCA disease treated with PCI in the Asia-Pacific region
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unprotected left main coronary artery disease treated with PCI | Other | Device: The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Lp(a) ≥ 70 mg/dL at the screening visit
- Optimal LDL-cholesterol lowering treatment
- Optimal treatment of other CV risk factors
- Myocardial infarction: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or
- Ischemic stroke: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or
Key exclusion criteria (6 listed)
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count <140,000 per μL
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 |
|---|---|---|
| The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting StentThe Angiolite stent is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design and a high overexpansion capacity that might overcomes some of these challenges in LMCA PCI. The ANGIOLITE randomized trial confirmed the non-inferiority of the Angiolite stent against the conventional DES | Device | unprotected left main coronary artery disease treated with PCI |
Primary outcome
Risk reduction of expanded MACE by TQJ230
Time frame: 51 months
To demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in 1) the overall study population with established CVD (Lp(a) ≥ 70 mg/dL) and/or 2) in a subpopulation with established CVD and Lp(a) ≥ 90 mg/dL.
2 secondary outcomes
MACE reduction by TQJ230
Time frame: 51 months
coronary heart disease (CHD) outcomes by TQJ230
Time frame: 51 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Bryan Yan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent in people with Cardiovascular Diseases, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 6 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 16 Feb 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 Hong Kong. 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?
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?
Risk reduction of expanded MACE by TQJ230 (time frame: 51 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 16 Feb 2024.