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

NCT05521542 | Active Not Recruiting FDA Device

• 1 other identifier: CPDNV-001
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Drug Coated Ballon; DCB; Coronary Artery Disease

Outcome Measures

Primary Outcomes (4)

• Device Success

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

  (Peri-procedural)

• 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

  (Peri-procedural)

• 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)

  (Peri-procedural)

• 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

  6 months post-procedure

Secondary Outcomes (13)

• All-cause death

  24 hours post-discharge

• Target Vessel Myocardial Infarction (TVMI)

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

• Major Adverse Cardiac Event (MACE)

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

• Target Vessel Failure (TVF)

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

• Target Lesion Failure (TLF)

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

Study Arms (1)

SirPlux™ Duo Dual-API Coated PTCA Balloon Catheter

EXPERIMENTAL

Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with SirPlux™.

Device: SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter

Interventions

SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter DEVICE

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

SirPlux™ Duo Dual-API Coated PTCA Balloon Catheter

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Advanced NanoTherapies: lead
• Monash University: collaborator
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (5)

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 50000, Australia

Location

Victorian Heart Institute - Monash University

Clayton, Victoria, 3168, Australia

Location

Cecanot Hospital

Santo Domingo, Dominican Republic

Location

Te Toka Tumai Auckland, Auckland City Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Stephen Nicholls

  Monash Heart

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, single-arm, feasibility study

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 30, 2022
• Study Start: January 30, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1); NZ (1); AU (3)