Complex Left Main Bifurcation StenosisCOMPETE-LMNCT07408674
COMPETE-LM Trial: Drug-Coated Balloon-Enhanced Provisional Stenting in Complex Left Main Disease.
A study testing Angiolite Sirolimus-Eluting Stenting and Essential Pro Paclitaxel Drug-Eluting Balloon in people with Complex Left Main Bifurcation Stenosis and Left Main Coronary Artery Stenosis, run by Rede Optimus Hospitalar SA.
Trial summary
Prospective, physician-initiated, multicenter, randomized, single-blind, controlled trial. Participants will be randomized (1:1) to a DCB-enhanced strategy (study group) or a conventional strategy (control group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Left Main Bifurcation Stenosis, Left Main Coronary Artery Stenosis, Coronary Bifurcation Stenosis
- What is being tested?
- Angiolite Sirolimus-Eluting Stenting and Essential Pro Paclitaxel Drug-Eluting Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to May 2029
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Distal left main stem bifurcation stenosis type Medina 1,1,1 or 0,1,1 with indication for revascularization.
- Left main diameter ≤6.00 mm.
- LAD and LCx diameter both >2.75 mm, evaluated by visual estimation.
Who cannot join
- Subjects with ages 18 or below at the time of the procedure.
- Female subjects who may be pregnant or breast-feeding at the time of the procedure.
- Previous PCI of the left main bifurcation.
- Chronic total occlusion of the LAD or LCx.
- Trifurcating left main requiring treatment of the 3 branches.
- LAD and LCx reference sizes are out of the sizing ranges of the used DES/DCB families.
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- In-stent restenosis as target lesion.
- Previous coronary artery bypass graft (CABG) with any patent graft on the left coronary system.
- ACS-STEMI (ST-Segment Elevation Myocardial Infarction) due to LM disease.
- Cardiogenic shock.
- Left ventricular ejection fraction below 35%.
- Decision to use mechanical circulatory support for protected PCI.
- Contraindication to a minimum of 3 months double antiplatelet and long-term single antiplatelet therapy (or adapted, in case of indication for anticoagulation).
- Associated significant valvular disease.
- Renal insufficiency with glomerular filtration rate (GFR) < 20.
- Life expectancy less than one year.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The COMPETE-LM Trial: A Physician-initiated Randomized Clinical Trial (RCT) Comparing Conventional Provisional Stenting With Drug-coated Balloon-enhanced Provisional Stenting for the Treatment of Complex Left Main (LM) Coronary Artery Disease.
Prospective, physician-initiated, multicenter, randomized, single-blind, controlled trial.
Participants will be randomized (1:1) to a DCB-enhanced strategy (study group) or a conventional strategy (control group).
Read more
The study aims to compare the clinical outcomes of conventional provisional stenting (Angiolite in the main branch, with optional side branch stenting if compromised) versus DCB enhanced provisional stenting (Angiolite in the main branch plus Essential Pro in the side branch) in patients with complex left main bifurcation stenosis indicated to receive non-urgent percutaneous coronary intervention (PCI).
Target lesions, both main vessel and side branch, will be treated using iVascular devices, with patients randomized into two arms. In one arm, treatment will be performed exclusively with the Angiolite sirolimus-eluting stent (Angiolite, iVascular) in the main vessel, while in the other arm, the Angiolite will be used in the main vessel and the Essential Pro paclitaxel drug-eluting balloon (Essential Pro, iVascular) in the side branch. Non-target lesions may be treated with any commercially available devices according to their approved indications.
- Conditions
- Complex Left Main Bifurcation Stenosis, Left Main Coronary Artery Stenosis, Coronary Bifurcation Stenosis
- Being tested
- Angiolite Sirolimus-Eluting Stenting, Essential Pro Paclitaxel Drug-Eluting Balloon
- Keywords
- Essential Pro Paclitaxel, Angiolite, Left Main Artery, Left Main Coronary Artery Stenosis, Left Main Coronary Artery, Left Main Bifurcation Stenosis, Coronary Disease, Coronary Artery Disease, Complex Left Main Disease, Drug Eluting Balloon, Drug Coated Balloon, Provisional Stenting, Sirolimus Eluting Stent
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiolite Sirolimus-Eluting StentingDevice
Also called Coronary Stent
Conventional Provisional Stenting
Essential Pro Paclitaxel Drug-Eluting BalloonDevice
Also called DBC, Drug Eluting Balloon, Drug Enhanced Balloon
Drug-Coated Balloon
| Study group | Role | What they receive |
|---|---|---|
| Conventional Stenting | Active comparator | Angiolite, iVascular Receives: Device: Angiolite Sirolimus-Eluting Stenting |
| DBC-enhanced Stenting | Experimental | Essential Pro, iVascular Receives: Device: Essential Pro Paclitaxel Drug-Eluting Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiography-based late lumen loss
Angiography-based late lumen loss at the level of treated side-branch (primarily not stented branch)
Measured: 12 months post procedure
Secondary outcomes (22)
2. Late lumen loss
Late lumen loss at the level of proximal- and distal main branch (primarily stented branch)
Measured: at 12 months post procedure
Stent thrombosis rate
Stent thrombosis rate (acute, subacute, late) at 12 months.
Measured: at 12 months post procedure
Optical coherence tomography (OCT)-based minimal stent / lumen area
Optical coherence tomography (OCT)-based minimal stent / lumen area at the level of LM, LAD ostium and left circumflex (LCx) ostium at 12 months.
Measured: at 12 months post procedure
OCT-based area stenosis
OCT-based area stenosis at the level of LM, LAD ostium and LCx ostium
Measured: at 12 months post procedure
Acute lumen gain (2D)
Acute lumen gain based on 2D quantitative coronary angiography
Measured: at index procedure
Acute lumen gain (3D)
Acute lumen gain based on 3D quantitative coronary angiography
Measured: at index procedure
Acute functional result
Acute functional result in the LAD and in the LCx, defined by Murray law-based quantitative flow ratio (μQFR)
Measured: at index procedure
Functional result in the LAD and in the LCx
Functional result in the LAD and in the LCx, defined by μQFR
Measured: at 12 months post procedure
Delta μQFR in the LAD and in the LCx
Delta μQFR in the LAD and in the LCx between acute (index procedure) and 12 months follow-up
Measured: at index procedure and at12 months post procedure
Malposition rate
Malapposition rate by OCT
Measured: at 12 months post procedure
Underexpansion rate
Underexpansion rate by OCT
Measured: at 12 months post procedure
Diameter stenosis
Diameter stenosis based on quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium
Measured: at 12 months post procedure
Area stenosis
Area stenosis based on 3D quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium
Measured: at 12 months post procedure
Conversion rate
Conversion rate to double-stent technique
Measured: at index procedure
Procedure time
Duration of index procedure
Measured: at index procedure
Used contrast media
Used contrast media at index procedure
Measured: at index procedure
Radiation dose
Radiation dose at index procedure
Measured: at index procedure
Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure
Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure
Measured: at 6 months and 12 months pos procedure
Death
Death upon 12 months
Measured: from index procedure to 12 months post procedure
Myocardial Infarction
Myocardial Infarction upon 12 months.
Measured: from index procedure to 12 months post procedure
Target vessel revascularization
Target vessel revascularization upon 12 months.
Measured: from index procedure to 12 months post procedure
Hospitalization for heart failure
Hospitalization for heart failure upon 12 months.
Measured: from index procedure to 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Left Main Bifurcation StenosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rede Optimus Hospitalar SA
- Sponsor type
- Research network
- Collaborators
- iVascular S.L.U.
- Responsible party
- Sponsor
- Investigators
- Gábor Tóth, MD, PhD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408674
- Sponsor's protocol ID
- RO-20250814
- Acronym
- COMPETE-LM
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 13 Feb 2026
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COMPETE-LM Trial: A Physician-initiated Randomized Clinical Trial (RCT) Comparing Conventional Provisional Stenting With Drug-coated Balloon-enhanced Provisional Stenting for the Treatment of Complex Left Main (LM) Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT07408674
- Acronym / sponsor ID
- COMPETE-LM / RO-20250814
- Conditions
- Complex Left Main Bifurcation Stenosis, Left Main Coronary Artery Stenosis, Coronary Bifurcation Stenosis
- Keywords
- Essential Pro Paclitaxel, Angiolite, Left Main Artery, Left Main Coronary Artery Stenosis, Left Main Coronary Artery, Left Main Bifurcation Stenosis, Coronary Disease, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Rede Optimus Hospitalar SAResearch network
- Collaborators
- iVascular S.L.U.
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 13 Feb 2026 (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.
Prospective, physician-initiated, multicenter, randomized, single-blind, controlled trial.
Participants will be randomized (1:1) to a DCB-enhanced strategy (study group) or a conventional strategy (control group).
The study aims to compare the clinical outcomes of conventional provisional stenting (Angiolite in the main branch, with optional side branch stenting if compromised) versus DCB enhanced provisional stenting (Angiolite in the main branch plus Essential Pro in the side branch) in patients with complex left main bifurcation stenosis indicated to receive non-urgent percutaneous coronary intervention (PCI).
Target lesions, both main vessel and side branch, will be treated using iVascular devices, with patients randomized into two arms. In one arm, treatment will be performed exclusively with the Angiolite sirolimus-eluting stent (Angiolite, iVascular) in the main vessel, while in the other arm, the Angiolite will be used in the main vessel and the Essential Pro paclitaxel drug-eluting balloon (Essential Pro, iVascular) in the side branch. Non-target lesions may be treated with any commercially available devices according to their approved indications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Stenting | Active comparator | Device: Angiolite Sirolimus-Eluting StentingAngiolite, iVascular |
| DBC-enhanced Stenting | Experimental | Device: Essential Pro Paclitaxel Drug-Eluting BalloonEssential Pro, iVascular |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Distal left main stem bifurcation stenosis type Medina 1,1,1 or 0,1,1 with indication for revascularization.
- Left main diameter ≤6.00 mm.
- LAD and LCx diameter both >2.75 mm, evaluated by visual estimation.
Key exclusion criteria (16 listed)
- Subjects with ages 18 or below at the time of the procedure.
- Female subjects who may be pregnant or breast-feeding at the time of the procedure.
- Previous PCI of the left main bifurcation.
- Chronic total occlusion of the LAD or LCx.
- Trifurcating left main requiring treatment of the 3 branches.
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 |
|---|---|---|
| Angiolite Sirolimus-Eluting StentingAlso: Coronary StentConventional Provisional Stenting | Device | Conventional Stenting |
| Essential Pro Paclitaxel Drug-Eluting BalloonAlso: DBC, Drug Eluting Balloon, Drug Enhanced BalloonDrug-Coated Balloon | Device | DBC-enhanced Stenting |
Primary outcome
Angiography-based late lumen loss
Time frame: 12 months post procedure
Angiography-based late lumen loss at the level of treated side-branch (primarily not stented branch)
22 secondary outcomes
2. Late lumen loss
Time frame: at 12 months post procedure
Stent thrombosis rate
Time frame: at 12 months post procedure
Optical coherence tomography (OCT)-based minimal stent / lumen area
Time frame: at 12 months post procedure
OCT-based area stenosis
Time frame: at 12 months post procedure
Acute lumen gain (2D)
Time frame: at index procedure
Acute lumen gain (3D)
Time frame: at index procedure
Acute functional result
Time frame: at index procedure
Functional result in the LAD and in the LCx
Time frame: at 12 months post procedure
Delta μQFR in the LAD and in the LCx
Time frame: at index procedure and at12 months post procedure
Malposition rate
Time frame: at 12 months post procedure
Underexpansion rate
Time frame: at 12 months post procedure
Diameter stenosis
Time frame: at 12 months post procedure
Area stenosis
Time frame: at 12 months post procedure
Conversion rate
Time frame: at index procedure
Procedure time
Time frame: at index procedure
Used contrast media
Time frame: at index procedure
Radiation dose
Time frame: at index procedure
Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure
Time frame: at 6 months and 12 months pos procedure
Death
Time frame: from index procedure to 12 months post procedure
Myocardial Infarction
Time frame: from index procedure to 12 months post procedure
Target vessel revascularization
Time frame: from index procedure to 12 months post procedure
Hospitalization for heart failure
Time frame: from index procedure to 12 months post procedure
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 13 Feb 2026.
- Individual participant dataSharing planned: No
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.
Gábor Tóth, MD, PhD principal investigator
Medical University of Graz
Questions about this trial
What is this clinical trial studying?
A study testing Angiolite Sirolimus-Eluting Stenting and Essential Pro Paclitaxel Drug-Eluting Balloon in people with Complex Left Main Bifurcation Stenosis and Left Main Coronary Artery Stenosis, run by Rede Optimus Hospitalar SA.
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 16 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: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Annelena Held, PhD, MSc (+49 157 86743867, annelena.held@redeoptimus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiography-based late lumen loss (time frame: 12 months post procedure). 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 13 Feb 2026.