With Left Main Coronary Artery LesionsNCT07004569
Angiolite Registry Study
An observational study of With Left Main Coronary Artery Lesions, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium. Percutaneous coronary intervention (PCI) using contemporary drug eluting stent (DES) is one of the treatment options for patients with significant LMCA disease and suitable anatomy as multiple randomized… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- With Left Main Coronary Artery Lesions
- What is being tested?
- Percutaneous coronary intervention (PCI)
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 May 2024to 28 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include up to 50 patients of both genders who meet the eligibility criteria listed below and agree to participate in the trial
Who may be able to join
- Subject age >18.
- Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent.
- Indication for a percutaneous coronary intervention (PCI) in native epicardial arteries involving left main coronary artery, including patients with stable coronary artery disease and acute coronary syndromes (non-ST-elevated myocardial infarction and ST-elevation myocardial infarction).
- Target lesion must have a stenosis of >50% and <100% angiographically.
- Target lesion much have an angiographic reference vessel diameter of 2.0-6.0 mm.
- All lesions requiring PCI should be amendable for implantation of study stents.
Who cannot join
- Known history of an allergic reaction or significant sensitivity to sirolimus or other analogue or derivative.
- Known history of an allergic reaction or significant sensitivity to fluoroacrylate or its analogue or derivative.
- Pregnant or breastfeeding woman.
- Currently participating in another device study that has not completed the primary end point or that clinically interferes with the current study endpoints.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, Shatin, 0000
Daniel Xu, 35051518 ext. 1518, danielxu@cuhk.edu.hk
About this study
Official title: A Prospective, Non-Randomized, Clinical Registry of The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent in The Treatment of Patients With Left Main Coronary Artery Lesions
Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium. Percutaneous coronary intervention (PCI) using contemporary drug eluting stent (DES) is one of the treatment options for patients with significant LMCA disease and suitable anatomy as multiple randomized controlled trials and meta-analysis have demonstrated the feasibility and safety of PCI in the treatment of LMCA disease. There are a few challenges in LMCA PCI due to certain anatomical and structural factors. The LMCA disease frequently involves bifurcations which requires special considerations such as side-branch access and preservation in order to prevent procedural related myocardial infarction (MI). Implantation of a metallic scaffold across the LMCA bifurcation often requires aggressive post-dilatation of the LMCA stent due to the diameter discrepancy between the side-branch and the LMCA main body. However, overexpansion beyond the rated diameter might compromise the stent integrity and radial force, resulting in mal-apposition, vascular recoil and risk of subsequent target lesion failure (TLF). 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. However, patients with LMCA involvement were specifically excluded from the trial. We therefore propose to investigate the procedural and 24 months clinical performance of the Angiolite stent in the treatment of patients with LMCA lesions.
Read the detailed description
Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium. Percutaneous coronary intervention (PCI) using contemporary drug eluting stent (DES) is one of the treatment options for patients with significant LMCA disease and suitable anatomy as multiple randomized controlled trials and meta-analysis have demonstrated the feasibility and safety of PCI in the treatment of LMCA disease. There are a few challenges in LMCA PCI due to certain anatomical and structural factors. The LMCA disease frequently involves bifurcations which requires special considerations such as side-branch access and preservation in order to prevent procedural related myocardial infarction (MI). Implantation of a metallic scaffold across the LMCA bifurcation often requires aggressive post-dilatation of the LMCA stent due to the diameter discrepancy between the side-branch and the LMCA main body. However, overexpansion beyond the rated diameter might compromise the stent integrity and radial force, resulting in mal-apposition, vascular recoil and risk of subsequent target lesion failure (TLF). 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. However, patients with LMCA involvement were specifically excluded from the trial. We therefore propose to investigate the procedural and 24 months clinical performance of the Angiolite stent in the treatment of patients with LMCA lesions.
- Conditions
- With Left Main Coronary Artery Lesions
- Being tested
- Percutaneous coronary intervention (PCI)
- Keywords
- Polymer-based Sirolimus-Eluting Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Device
Patients is under Percutaneous coronary intervention (PCI) by using contemporary drug eluting stent (DES). Angiolite is a thin-strut cobalt-chromium durable fluoroacrylate polymer-based, sirolimus-eluting stent that is CE marked and commercially available. Stent sizes 2.0mm to 4.5mm in 9mm to 49mm lengths will be used.
| Study group | Role | What they receive |
|---|---|---|
| Patients using AngioliteTM Stent with Left Main Coronary Artery Lesions | This is an investigator-initiated, prospective, single-centre, non-randomized registry that evaluates the safety and efficacy of the AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent (iVascular, Barcelona, Spain) for the treatment of LMCA disease. Receives: Device: Percutaneous coronary intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Device oriented clinical endpoint (DOCE)
Device oriented clinical endpoint (DOCE) defined as a composite of cardiovascular death, myocardial infarction (Q-wave and non-Q wave), emergent coronary artery bypass graft surgery, target vessel myocardial infarction (TV-MI) or repeat clinically driven target-lesion revascularization (TLR) by percutaneous or surgical methods.
Measured: baseline, 1 month, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start28 May 2024
- Primary completion30 May 2025 (estimated)
- Study completion28 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for With Left Main Coronary Artery LesionsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GuangMing Tan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004569
- Sponsor's protocol ID
- 2024.682
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Randomized, Clinical Registry of The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent in The Treatment of Patients With Left Main Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT07004569
- Acronym / sponsor ID
- 2024.682
- Conditions
- With Left Main Coronary Artery Lesions
- Keywords
- Polymer-based Sirolimus-Eluting Stent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 28 Jul 2025 (estimated)
- First posted
- 4 Jun 2025 (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.
Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium. Percutaneous coronary intervention (PCI) using contemporary drug eluting stent (DES) is one of the treatment options for patients with significant LMCA disease and suitable anatomy as multiple randomized controlled trials and meta-analysis have demonstrated the feasibility and safety of PCI in the treatment of LMCA disease. There are a few challenges in LMCA PCI due to certain anatomical and structural factors. The LMCA disease frequently involves bifurcations which requires special considerations such as side-branch access and preservation in order to prevent procedural related myocardial infarction (MI). Implantation of a metallic scaffold across the LMCA bifurcation often requires aggressive post-dilatation of the LMCA stent due to the diameter discrepancy between the side-branch and the LMCA main body. However, overexpansion beyond the rated diameter might compromise the stent integrity and radial force, resulting in mal-apposition, vascular recoil and risk of subsequent target lesion failure (TLF). 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. However, patients with LMCA involvement were specifically excluded from the trial. We therefore propose to investigate the procedural and 24 months clinical performance of the Angiolite stent in the treatment of patients with LMCA lesions.
Detailed description
Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium. Percutaneous coronary intervention (PCI) using contemporary drug eluting stent (DES) is one of the treatment options for patients with significant LMCA disease and suitable anatomy as multiple randomized controlled trials and meta-analysis have demonstrated the feasibility and safety of PCI in the treatment of LMCA disease. There are a few challenges in LMCA PCI due to certain anatomical and structural factors. The LMCA disease frequently involves bifurcations which requires special considerations such as side-branch access and preservation in order to prevent procedural related myocardial infarction (MI). Implantation of a metallic scaffold across the LMCA bifurcation often requires aggressive post-dilatation of the LMCA stent due to the diameter discrepancy between the side-branch and the LMCA main body. However, overexpansion beyond the rated diameter might compromise the stent integrity and radial force, resulting in mal-apposition, vascular recoil and risk of subsequent target lesion failure (TLF). 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. However, patients with LMCA involvement were specifically excluded from the trial. We therefore propose to investigate the procedural and 24 months clinical performance of the Angiolite stent in the treatment of patients with LMCA lesions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients using AngioliteTM Stent with Left Main Coronary Artery Lesions | – | Device: Percutaneous coronary intervention (PCI)This is an investigator-initiated, prospective, single-centre, non-randomized registry that evaluates the safety and efficacy of the AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent (iVascular, Barcelona, Spain) for the treatment of LMCA disease. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include up to 50 patients of both genders who meet the eligibility criteria listed below and agree to participate in the trial
Key inclusion criteria (6 listed)
- Subject age >18.
- Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent.
- Indication for a percutaneous coronary intervention (PCI) in native epicardial arteries involving left main coronary artery, including patients with stable coronary artery disease and acute coronary syndromes (non-ST-elevated myocardial infarction and ST-elevation myocardial infarction).
- Target lesion must have a stenosis of >50% and <100% angiographically.
- Target lesion much have an angiographic reference vessel diameter of 2.0-6.0 mm.
Key exclusion criteria (4 listed)
- Known history of an allergic reaction or significant sensitivity to sirolimus or other analogue or derivative.
- Known history of an allergic reaction or significant sensitivity to fluoroacrylate or its analogue or derivative.
- Pregnant or breastfeeding woman.
- Currently participating in another device study that has not completed the primary end point or that clinically interferes with the current study endpoints.
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 intervention (PCI)Patients is under Percutaneous coronary intervention (PCI) by using contemporary drug eluting stent (DES). Angiolite is a thin-strut cobalt-chromium durable fluoroacrylate polymer-based, sirolimus-eluting stent that is CE marked and commercially available. Stent sizes 2.0mm to 4.5mm in 9mm to 49mm lengths will be used. | Device | Patients using AngioliteTM Stent with Left Main Coronary Artery Lesions |
Primary outcome
change in Device oriented clinical endpoint (DOCE)
Time frame: baseline, 1 month, 6 months, 12 months, 24 months
Device oriented clinical endpoint (DOCE) defined as a composite of cardiovascular death, myocardial infarction (Q-wave and non-Q wave), emergent coronary artery bypass graft surgery, target vessel myocardial infarction (TV-MI) or repeat clinically driven target-lesion revascularization (TLR) by percutaneous or surgical methods.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
Related trials for With Left Main Coronary Artery Lesions
Recruiting
"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI
Coronary Artery Disease (CAD), Chronic Coronary Syndrome
RecruitingObservational study
Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions
Coronary Bifurcation Lesion, Coronary Artery Disease (CAD)
Not yet recruiting
The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations
Coronary Artery Disease (non-left Main), Coronary Bifurcation Lesion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of With Left Main Coronary Artery Lesions, 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 4 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: looking for participants now, as of the sponsor's last update on 4 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Device oriented clinical endpoint (DOCE) (time frame: baseline, 1 month, 6 months, 12 months, 24 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 4 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.