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

NCT07368933 | Recruiting FDA Device

• 1 other identifier: ANT-00001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

The study objectives are:

1. 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. 2.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

Keywords

DCB; Drug Coated Balloon; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Target lesion failure rate (TLF)

  Target lesion failure rate (TLF) at 12 months post-procedure

  12 Months

Secondary Outcomes (6)

• Performance - Device Sucess

  Peri-procedural

• Performance - Lesion Success

  Peri-procedural

• Performance - Procedural Success

  Peri-Procedural through 7 days post-Procedure

• Late Lumen Loss

  6 months post procedure

• Safety

  24 months post procedure

Study Arms (1)

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

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

Interventions

SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter DEVICE

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

SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter

Eligibility Criteria

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

You may qualify if:

• ≥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
• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Advanced NanoTherapies: lead

Study Sites (3)

Hospital Clínic de Barcelona

Barcelona, Spain

RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, Spain

RECRUITING

Hospital Alvaro Cunqueiro

Vigo, Spain

RECRUITING

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease; Angina, Unstable; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Central Study Contacts

Marwan Berrada-Sounni

CONTACT

(415) 517-0867; mberrada@advnanot.com

Study Design

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

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 27, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)