Angina (Stable)ADVANCE-DUONCT07368933
Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic Coronary Artery Disease
A study testing SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter in people with Angina (Stable) and CAD - Coronary Artery Disease, run by Advanced NanoTherapies at 3 sites in Spain.
Trial summary
The study objectives are: 1. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina (Stable), CAD - Coronary Artery Disease, Unstable Angina
- What is being tested?
- SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesSpain
- Study dates
- 15 Dec 2025to Jan 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
- ≥18 years or minimum legal age as required by local regulations.
- Documented stable or unstable angina, positive functional test, or non -ST elevation myocardial infarction which, in the judgment of the operator, is attributable to disease in coronary vessel or in-stent restenosis, and the patient is deemed an appropriate candidate for PCI in accordance with the applicable guidelines on percutaneous coronary intervention.
- Note: participants with NSTEMI must have enzymes that are trending down or are within normal limits prior to enrollment.
- Life expectancy >1 year in the Investigator's opinion.
- Participant is willing and able to cooperate with study procedures and follow-up evaluations.
- Treatment of only one target lesion required
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- Tandem lesions treated by a single DCB will be considered one target lesion.
- Up to one de novo lesion in a separate vessel may be treated per standard of care at the procedure. Non-target lesions must be successfully treated under the same criteria of the target lesion, before treating the target lesion.
- Target lesion must be ≤36 mm in length.
- Target lesion must have a stenosis ≥ 50% and < 100%.
- Target lesion must have a visually estimated reference vessel diameter of:
- ISR lesions: 2.0 to 4.0 mm in diameter (inclusive)
- de novo lesions: 2.0 to <3.0 mm in diameter
- ISR lesions only: target lesion must be within a previous BMS or DES that does not extend >5.0 mm beyond the proximal or distal edge.
Who cannot join
- Participant is pregnant, or breastfeeding. Note: Participant of childbearing potential must have a negative pregnancy test within 7 days before procedure.
- Known hypersensitivity or contraindication to antiplatelet medications (e.g., aspirin; heparin; prasugrel); or a sensitivity to contrast media which cannot be adequately pre-medicated.
- History of an allergic reaction or significant sensitivity to paclitaxel, sirolimus, or any other analogue or derivative.
- Platelet count < 100,000 cells/mm³ (i.e., 100 x 109 /L) or > 700,000 cells/mm³ (i.e., 700 x 10 9 /L), or a white blood cell (WBC) count < 3,000 cells/mm³ within 7 days prior to procedure.
- Renal insufficiency (Serum creatinine level > 2.5 mg/dl (i.e., 221 μmol/L) within 7 days prior to procedure) or failure (dialysis dependent).
- Evidence of an acute MI within 72 hours of the procedure Note: participants with NSTEMI are allowed, provided enzymes are trending down or are within normal limits prior to enrollment.
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- Previous PCI of the target vessel within 6 months prior to procedure.
- History of a stroke or transient ischemic attack (TIA) within the prior 3 months to procedure (any prior stroke or TIA, if prasugrel is used).
- Planned PCI of any vessel within 30 days post-procedure and/or planned PCI of the target vessel within 12 months post-procedure.
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months to procedure.
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Documented left ventricular ejection fraction (LVEF) <30% at the most recent evaluation, within the prior 3 months to procedure.
- Planned surgery that would cause interruption in recommended DAPT duration per current guidelines.
- Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, IVUS, or other coronary artery imaging procedures.
- The following criteria related to previous treatments applies based on the type of lesion treated. The participant is excluded in the following circumstances:
- ISR lesions: If single-layer ISR, any previous treatment of the target vessel for restenosis. If double- layer ISR, any treatment of the double-layer ISR.
- de novo lesions: any previous treatment of the target lesion.
- Planned PCI of three vessel disease during procedure.
- Planned treatment of more than one target vessel. Tandem lesions that can be treated by a single DCB are permissible.
- Target lesion requires treatment with atherectomy, laser, or thrombectomy procedure.
- Target vessel has other lesions with greater than 50% diameter stenosis based on visual estimate.
- Target vessel has evidence of thrombus.
- Target vessel is excessively tortuous, defined as more than one bend >90° to reach target lesion.
- Target lesion has any of following characteristics:
- Lesion location is unprotected in left main coronary artery, internal mammary artery, aorto-ostial, bypass grafts, ostial lesions or within 5 mm of the origin of the left anterior descending or left circumflex.
- Involves a side branch >2.0 mm in diameter.
- Is severely calcified.
- The following criteria based on number and type of lesions:
- ISR and de novo lesions: target lesion is in the same vessel with a de novo lesion requiring treatment.
- ISR lesions: planned treatment of a ≥3 layer ISR lesion.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander
- Recruiting
Hospital Alvaro Cunqueiro
Vigo
About this study
Official title: ADVANCEd NanoTherapies SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter to Treat Coronary In-stent Restenosis (ISR) and de Novo Lesions
The study objectives are:
- To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease.
- To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary de novo lesions <3.00 mm in diameter in patients with symptomatic coronary artery disease.
- Conditions
- Angina (Stable), CAD - Coronary Artery Disease, Unstable Angina, NSTEMI - Non-ST Segment Elevation MI
- Being tested
- SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter
- Keywords
- DCB, Drug Coated Balloon, Coronary Artery Disease
- Medical subject headings
- Angina, Stable, Coronary Artery Disease, Angina, Unstable, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirPlux Duo™ Dual API-Coated PTCA Balloon CatheterDevice
SirPlux Duo PTCA is a Drug-Coated Balloon to treat de novo and In-Stent Restenosis lesions in patients with symptomatic stable angina, unstable angina or NSTEMI
| Study group | Role | What they receive |
|---|---|---|
| SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter | Experimental | Subject who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with SirPlux DUO PTCA Receives: Device: SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure rate (TLF)
Target lesion failure rate (TLF) at 12 months post-procedure
Measured: 12 Months
Secondary outcomes (6)
Performance - Device Sucess
Device Success: Defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device.
Measured: Peri-procedural
Performance - Lesion Success
Defined as achievement of ≤30% residual stenosis (by visual estimate) of the target lesion upon SirPlux Duo PTCA treatment
Measured: Peri-procedural
Performance - Procedural Success
Defined as device and lesion success, and absence of procedural complications following study device inflation (i.e., absence of significant vessel dissection [Grade C or higher] or loss of TIMI 3 flow) through 7 days post-procedure
Measured: Peri-Procedural through 7 days post-Procedure
Late Lumen Loss
Late Lumen Loss based on QCA
Measured: 6 months post procedure
Safety
- All Death
- Cardiac death
- All myocardial infarction (MI), including target vessel myocardial infarction (TVMI)
- Ischemia driven target lesion revascularization (TLR) defined as revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis ≥ 50% by QCA.
- Clinically driven target lesion revascularization (cd-TLR) defined as revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis ≥ 50% by QCA, or revascularization of a target lesion with diameter stenosis ≥ 70% by QCA without either angina or a positive functional study.
- Ischemia driven target vessel revascularization (TVR) defined as revascularization at the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis ≥ 50% by QCA.
Measured: 24 months post procedure
Safety
- Clinically driven target vessel revascularization (cd-TVR) defined as revascularization at the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis ≥ 50% by QCA, or revascularization of a target lesion with diameter stenosis ≥ 70% by QCA without either angina or a positive functional study h. Major adverse cardiac event (MACE) defined as composite of death, MI, or repeat TLR i. Target lesion failure (TLF) defined as composite of cardiac death, TVMI, or TLR j. Target vessel failure (TVF) defined as composite of cardiac death, TVMI, or TVR k. Target lesion thrombosis (TLT) (definite or probable) according to Academic Research Consortium (ARC) definition
Measured: 24 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 posted27 Jan 2026
- Study start15 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina (Stable)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced NanoTherapies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368933
- Sponsor's protocol ID
- ANT-00001
- Acronym
- ADVANCE-DUO
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADVANCEd NanoTherapies SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter to Treat Coronary In-stent Restenosis (ISR) and de Novo Lesions
- ClinicalTrials.gov ID
- NCT07368933
- Acronym / sponsor ID
- ADVANCE-DUO / ANT-00001
- Conditions
- Angina (Stable), CAD - Coronary Artery Disease, Unstable Angina, NSTEMI - Non-ST Segment Elevation MI
- Keywords
- DCB, Drug Coated Balloon, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Advanced NanoTherapiesIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 27 Jan 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.
The study objectives are:
- To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease.
- To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary de novo lesions <3.00 mm in diameter in patients with symptomatic coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter | Experimental | Device: SirPlux Duo™ Dual API-Coated PTCA Balloon CatheterSubject who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with SirPlux DUO PTCA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ≥18 years or minimum legal age as required by local regulations.
- Documented stable or unstable angina, positive functional test, or non -ST elevation myocardial infarction which, in the judgment of the operator, is attributable to disease in coronary vessel or in-stent restenosis, and the patient is deemed an appropriate candidate for PCI in accordance with the applicable guidelines on percutaneous coronary intervention.
- Note: participants with NSTEMI must have enzymes that are trending down or are within normal limits prior to enrollment.
- Life expectancy >1 year in the Investigator's opinion.
- Participant is willing and able to cooperate with study procedures and follow-up evaluations.
Key exclusion criteria (30 listed)
- Participant is pregnant, or breastfeeding. Note: Participant of childbearing potential must have a negative pregnancy test within 7 days before procedure.
- Known hypersensitivity or contraindication to antiplatelet medications (e.g., aspirin; heparin; prasugrel); or a sensitivity to contrast media which cannot be adequately pre-medicated.
- History of an allergic reaction or significant sensitivity to paclitaxel, sirolimus, or any other analogue or derivative.
- Platelet count < 100,000 cells/mm³ (i.e., 100 x 109 /L) or > 700,000 cells/mm³ (i.e., 700 x 10 9 /L), or a white blood cell (WBC) count < 3,000 cells/mm³ within 7 days prior to procedure.
- Renal insufficiency (Serum creatinine level > 2.5 mg/dl (i.e., 221 μmol/L) within 7 days prior to procedure) or failure (dialysis dependent).
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 |
|---|---|---|
| SirPlux Duo™ Dual API-Coated PTCA Balloon CatheterSirPlux Duo PTCA is a Drug-Coated Balloon to treat de novo and In-Stent Restenosis lesions in patients with symptomatic stable angina, unstable angina or NSTEMI | Device | SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter |
Primary outcome
Target lesion failure rate (TLF)
Time frame: 12 Months
Target lesion failure rate (TLF) at 12 months post-procedure
6 secondary outcomes
Performance - Device Sucess
Time frame: Peri-procedural
Performance - Lesion Success
Time frame: Peri-procedural
Performance - Procedural Success
Time frame: Peri-Procedural through 7 days post-Procedure
Late Lumen Loss
Time frame: 6 months post procedure
Safety
Time frame: 24 months post procedure
Safety
Time frame: 24 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 27 Jan 2026.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter in people with Angina (Stable) and CAD - Coronary Artery Disease, run by Advanced NanoTherapies at 3 sites in Spain.
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 14 inclusion and 30 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Contact Marwan Berrada-Sounni ((415) 517-0867, mberrada@advnanot.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure rate (TLF) (time frame: 12 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 27 Jan 2026.