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Coronary Artery DiseaseADVANCE-DCBNCT05521542

Advanced NanoTherapies Dual-API DCB to Treat De-Novo Lesions in Patients With Symptomatic Coronary Artery Disease

A study testing SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter in people with Coronary Artery Disease, run by Advanced NanoTherapies at 5 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This prospective, single-arm, multi-center, safety and feasibility first-in-human study will evaluate the safety and feasibility of the SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter to treat de-novo lesions between ≥2.0 and ≤4.0 mm in patients with symptomatic stable angina, unstable angina, and NSTEMI. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Coronary Artery Disease
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
28 participants
Where
5 sitesin 3 countries
Study dates
30 Jan 2023to Mar 2027
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 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is ≥18 years and <90 years old.
  • Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed.
  • Subject has been diagnosed with a symptomatic stable angina, or acute coronary syndrome.
  • Life expectancy > 1 year.
  • The subject is planned to undergo a percutaneous coronary intervention for a known lesion meeting the angiographic criteria set out below.
  • Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure. Men with a female partner of childbearing potential must agree to use condoms plus an additional reliable contraceptive method within 12 months after the index procedure.
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  • The subject is able and willing to comply with all assessments in the study, including dual antiplatelet therapy (DAPT), ASA indefinitely, and P2Y12 inhibitor for a minimum of 6 months for stable angina subjects, and 12 months for unstable angina and NSTEMI subjects.
  • The subject shall be under optimal medical therapy for ASCVD, which includes at a minimum high-intensity statin therapy. If statin intolerant, the subject should be treated with a PCSK9 inhibitor, ezetimibe or bempedoic acid.
  • Angiographic Inclusion Criteria:
  • Target lesion is located within a de-novo lesion located in a native coronary artery with a reference vessel diameter between and including 2.0 mm and 4.0mm by visual estimate, with an in-segment length <=36mm. Target lesions must have a visually estimated stenosis of ≥50% and be <100% in symptomatic subjects prior to lesion pre-dilation.
  • Subject has one or two lesions that meet inclusion and exclusion criteria individually that could be treated with a study device.
  • If multiple lesions are treated, only two may be treated with the investigational device.
  • If two lesions are treated with the investigational device, they must be in different vessels.
  • Non-target lesions (lesion to be treated with something other than the investigational device) may be treated at either baseline or staged PCI but never in the same vessel as the target lesion.
  • Successful pre-dilation with semi and/or non-compliant balloon of the target lesion(s) (defined as no major flow-limiting dissections (Grade C or higher) and <30% residual stenosis of the target lesion by a visual estimate on angiography). Adjunctive pre-dilation therapies such as scoring balloon, cutting balloon, and IVL are allowed. Rotablator or similar rotational atherectomy devices are restricted per protocol.

Who cannot join

  • General Exclusion Criteria:
  • Subject has current problems with substance abuse.
  • Subject has a planned procedure that may cause non-compliance with the protocol.
  • Subject participates in another investigational drug or device clinical study that has not reached its primary endpoint.
  • Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.
  • Chronic total occlusion (CTO) of the target lesion(s) or Thrombolysis In Myocardial Infarction (TIMI) flow < 2.
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  • Subject requires treatment of a coronary lesion(s) involving a bifurcation with significant ostial / proximal disease within 5mm of a side-branch greater than 2.0mm.
  • Target lesion(s) within native or synthetic vessel grafts.
  • Subject has had any major (e.g., cardiac, and non-cardiac) surgical procedure or intervention unrelated to this study within 30 days before the index procedure or has a planned major surgical procedure or intervention within 30 days of the index procedure. The exception will be made in case of planned staged PCI procedures for other coronary lesions (study or non-study lesion) lesions, whereby the timeframe between procedures shall be determined by the clinical stability of the subject as assessed by the treating investigator. The subject must re-meet the inclusion criteria and be free from any exclusion criteria before enrolment.
  • The subject has a known coagulopathy or has a bleeding diathesis, thrombocytopenia (with platelet counts less than 100,000/microliter) or platelets > 450,000/microliter, or international normalized ratio >1.5. Subjects on chronic oral anticoagulation medications will be excluded of the study.
  • Known renal insufficiency, estimated glomerular filtration rate (eGFR) ≤30 mL/min, by institutional calculation.
  • Subject on dialysis, or acute kidney failure (as per physician judgment).
  • Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated or hypersensitive.
  • Subject has a known allergy to contrast agents or medications used to perform a coronary intervention that cannot be adequately pre-treated, including, but not limited to, sirolimus, paclitaxel, aspirin, heparin, clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor.
  • Subject has a known allergy to urethane, nylon, or silicone.
  • Presentation and index admission with STEMI. An exception to this exclusion is the treatment of the non-culprit target lesion with study device during a staged PCI procedure which can be either during the index STEMI admission (but not at the time of primary PCI) or electively at another date.
  • Type 2 NSTEMI
  • Presentation with ACS and ongoing chest pain and/or hemodynamic instability despite treatment of the culprit lesion
  • History of stroke/TIA within 60 days before enrollment.
  • LVEF less than or equal to 35%.
  • Subject is confined to bed.
  • History of thrombolytic therapy within two weeks of enrollment.
  • Subject is a recipient of a heart transplant.
  • Subject is unwilling/not able to return for angiographic catheterization at 6-month follow-up.
  • Women who are pregnant, breast-feeding or intend to become pregnant.
  • Subject has other medical, social, or psychological problems and is unwilling or unable to comply with procedures specified in the protocol or may have difficulty returning for follow-up visits as specified by the protocol.
  • Cardiogenic shock (SBP <80mmHg requiring inotropes, IABP, or fluid support).
  • Subject has symptomatic active COVID-19 or is asymptomatic within the past 2 weeks of a positive COVID test.
  • Angiographic Exclusion Criteria:
  • Subject has a planned intervention in the left-main plus two separate major epicardial territories (left-main plus 2 vessel diseases).
  • Target vessel size <2.00 mm or >4.0 mm
  • Target lesion in the left main stem.
  • Target vessel with high thrombus burden.
  • Aorto-ostial target RCA lesion (within < 10 mm of the aorta junction)
  • Moderate-severe tortuous, calcified, or angulated coronary anatomy of the target vessel that, in the opinion of the Investigator, would result in suboptimal imaging or excessive risk of complication from placement of an IVUS catheter following Clinical Decision.
  • The lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft.
  • Target lesion is located within a previous implanted stent.

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Australia3 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 50000

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Victorian Heart Institute - Monash University

    Clayton, Victoria, 3168

Other trials in Australia

Dominican Republic1 site

  • Cecanot Hospital

    Santo Domingo

Other trials in Dominican Republic

New Zealand1 site

  • Te Toka Tumai Auckland, Auckland City Hospital

    Auckland

Other trials in New Zealand

About this study

Official title: ADVANCEd NanoTherapies Dual Active Pharmacological Ingredient (Dual-API) Drug-Coated Balloon Catheter to Treat De-Novo Lesions in Patients With Symptomatic Stable Angina, Unstable Angina, and NSTEMI

This prospective, single-arm, multi-center, safety and feasibility first-in-human study will evaluate the safety and feasibility of the SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter to treat de-novo lesions between ≥2.0 and ≤4.0 mm in patients with symptomatic stable angina, unstable angina, and NSTEMI.

Read the detailed description

The SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter is an investigational medical device to be used to treat de-novo lesions in patients with symptomatic stable angina, unstable angina, and NSTEMI. In this study, SirPlux Duo™ will be used in subjects undergoing a planned percutaneous coronary intervention. The population to treat will include those with de-novo coronary lesions in vessels with a reference vessel diameter (RVD) of ≥2.0 and ≤4.0 mm and a total lesion length of <36mm with documented symptomatic stable angina, unstable angina, or NSTEMI. The study is a prospective, single-arm, multi-center, safety and feasibility first-in-human study designed to generate descriptive data about the use of SirPlux Duo™.

Being tested
SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter
Keywords
Drug Coated Ballon, DCB, Coronary Artery Disease
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.

  • SirPlux Duo™ Dual-API Coated PTCA Balloon CatheterDevice

    SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter is a Drug-Coated Balloon to treat de novo lesions in patients with symptomatic stable angina, unstable angina, or NSTEMI

Study groups in NCT05521542
Study groupRoleWhat they receive
SirPlux™ Duo Dual-API Coated PTCA Balloon CatheterExperimentalSubjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with SirPlux™.
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.

  1. Device Success

    Defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device without burst below rated burst pressure

    Measured: (Peri-procedural)

  2. Technical Success

    Defined as successful lesion crossing, completion of POBA and immediate achievement of <=30% residual stenosis (by QCA) of the target lesion upon completion of angiography post investigational device inflation

    Measured: (Peri-procedural)

  3. Procedural Success

    Defined as device success and technical success and absence of procedural complications following SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter inflation (ie absence of vessel dissection or loss of TIMI 3 flow)

    Measured: (Peri-procedural)

  4. In-segment Late Lumen Loss (LLL) by QCA

    difference in minimum lumen diameter, as determined by QCA, from baseline (immediately post-DCB) to 6 months post-procedure

    Measured: 6 months post-procedure

Secondary outcomes (13)

  1. All-cause death

    All-cause death, including death during procedure and up to 24 hours after discharge

    • Target Vessel Myocardial Infarction (TVMI).
    • Cardiac death
    • Myocardial Infarction (MI)
    • Emergent Coronary Artery Bypass Graft (CABG)
    • Repeat Target Lesion Revascularization (TLR) (clinically driven) by percutaneous or surgical methods
    • Major Adverse Cardiac Event (MACE)
    • Target Vessel Failure (TVF)
    • Target Lesion Failure (TLF)
    • All revascularizations (TLR, TVR and non-TVR)

    Measured: 24 hours post-discharge

  2. Target Vessel Myocardial Infarction (TVMI)

    • Target Vessel Myocardial Infarction (TVMI)

    Measured: 30 days, 6 months, 12 months and 24 months post-procedure

  3. Major Adverse Cardiac Event (MACE)

    • Major Adverse Cardiac Event (MACE) is defined as the composite of cardiac death, Myocardial Infarction (MI), emergent Coronary Artery Bypass Graft (CABG), or repeat Target Lesion Revascularization (TLR) (clinically driven) by percutaneous or surgical methods

    Measured: 30 days, 6 months, 12 months and 24 months post-procedure

  4. Target Vessel Failure (TVF)

    • Target Vessel Failure (TVF) is defined as cardiac death, TVMI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods of the target vessel

    Measured: 30 days, 6 months, 12 months and 24 months post-procedure

  5. Target Lesion Failure (TLF)

    • Target Lesion Failure (TLF) is defined by a composite of cardiac death, TVMI, or clinically driven TLR by percutaneous or surgical methods of the index lesion

    Measured: 30 days, 6 months, 12 months and 24 months post-procedure

  6. All revascularizations (TLR, TVR and non-TVR)

    • All revascularizations (TLR, TVR and non-TVR) as a composite of TLR, TVR, and non-TVR

    Measured: 30 days, 6 months, 12 months and 24 months post-procedure

  7. In-segment (in balloon) percent diameter stenosis (%DS) by QCA

    In-segment (in balloon) percent diameter stenosis (% diameter stenosis; %DS).

    Measured: 6 months post-procedure

  8. In-segment binary angiographic restenosis (BAR) rate by QCA

    In-segment binary angiographic restenosis (BAR) is defined as ≥50% diameter stenosis.

    Measured: 6 months post-procedure

  9. In-segment Minimum Luminal/Lumen Diameter (MLD) by QCA

    In-segment Minimum Luminal/Lumen Diameter (MLD) change from baseline to 6 months post-procedure

    Measured: 6 months post-procedure

  10. In-segment Change in IVUS minimum lumen area (MLA, mm2) by IVUS

    In-segment Change in IVUS MLA (mm2) from baseline to 6 months post-procedure

    Measured: at 6 months post-procedure

  11. In-segment change in mean lumen area (mm2) by IVUS

    In-segment change in mean lumen area (mm2) from baseline to 6 months post-procedure

    Measured: 6 months post-procedure

  12. In-segment change in percentage atheroma volume by IVUS

    In-segment change in percentage atheroma volume from baseline to 6 months post-procedure

    Measured: 6 months post-procedure

  13. In-segment serial IVUS remodeling

    In-segment Serial IVUS remodeling (change in vessel area or volume) from baseline to 6 months post-procedure

    Measured: 6 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2022
  2. Study start30 Jan 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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
Model description
Prospective, multi-center, single-arm, feasibility study
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05521542
Sponsor's protocol ID
CPDNV-001
Acronym
ADVANCE-DCB
Status last verified
Sep 2025
First submitted
25 Aug 2022
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter in people with Coronary Artery Disease, run by Advanced NanoTherapies at 5 sites in 3 countries.

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 15 inclusion and 37 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: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia, Dominican Republic, New Zealand. 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?

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?

Device Success (time frame: (Peri-procedural)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05521542.

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 3 Oct 2025.

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