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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05521542




Registration number
NCT05521542
Ethics application status
Date submitted
25/08/2022
Date registered
30/08/2022
Date last updated
12/07/2024

Titles & IDs
Public title
Advanced NanoTherapies Dual-API DCB to Treat De-Novo Lesions in Patients With Symptomatic Coronary Artery Disease
Scientific 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
Secondary ID [1] 0 0
CPDNV-001
Universal Trial Number (UTN)
Trial acronym
ADVANCE-DCB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter

Experimental: SirPlux™ Duo Dual-API Coated PTCA Balloon Catheter - 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™.


Treatment: Devices: SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Device Success
Timepoint [1] 0 0
(Peri-procedural)
Primary outcome [2] 0 0
Technical Success
Timepoint [2] 0 0
(Peri-procedural)
Primary outcome [3] 0 0
Procedural Success
Timepoint [3] 0 0
(Peri-procedural)
Primary outcome [4] 0 0
In-segment Late Lumen Loss (LLL) by QCA
Timepoint [4] 0 0
6 months post-procedure
Secondary outcome [1] 0 0
All-cause death
Timepoint [1] 0 0
24 hours post-discharge
Secondary outcome [2] 0 0
Target Vessel Myocardial Infarction (TVMI)
Timepoint [2] 0 0
30 days, 6 months, 12 months and 24 months post-procedure
Secondary outcome [3] 0 0
Major Adverse Cardiac Event (MACE)
Timepoint [3] 0 0
30 days, 6 months, 12 months and 24 months post-procedure
Secondary outcome [4] 0 0
Target Vessel Failure (TVF)
Timepoint [4] 0 0
30 days, 6 months, 12 months and 24 months post-procedure
Secondary outcome [5] 0 0
Target Lesion Failure (TLF)
Timepoint [5] 0 0
30 days, 6 months, 12 months and 24 months post-procedure
Secondary outcome [6] 0 0
All revascularizations (TLR, TVR and non-TVR)
Timepoint [6] 0 0
30 days, 6 months, 12 months and 24 months post-procedure
Secondary outcome [7] 0 0
In-segment (in balloon) percent diameter stenosis (%DS) by QCA
Timepoint [7] 0 0
6 months post-procedure
Secondary outcome [8] 0 0
In-segment binary angiographic restenosis (BAR) rate by QCA
Timepoint [8] 0 0
6 months post-procedure
Secondary outcome [9] 0 0
In-segment Minimum Luminal/Lumen Diameter (MLD) by QCA
Timepoint [9] 0 0
6 months post-procedure
Secondary outcome [10] 0 0
In-segment Change in IVUS minimum lumen area (MLA, mm2) by IVUS
Timepoint [10] 0 0
at 6 months post-procedure
Secondary outcome [11] 0 0
In-segment change in mean lumen area (mm2) by IVUS
Timepoint [11] 0 0
6 months post-procedure
Secondary outcome [12] 0 0
In-segment change in percentage atheroma volume by IVUS
Timepoint [12] 0 0
6 months post-procedure
Secondary outcome [13] 0 0
In-segment serial IVUS remodeling
Timepoint [13] 0 0
6 months post-procedure

Eligibility
Key inclusion criteria
1. The subject is =18 years and <90 years old.
2. 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.
3. Subject has been diagnosed with a symptomatic stable angina, or acute coronary syndrome.
4. Life expectancy > 1 year.
5. The subject is planned to undergo a percutaneous coronary intervention for a known lesion meeting the angiographic criteria set out below.
6. 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.
7. 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.
8. 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
9. 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.
10. 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.
11. 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.
Minimum age
18 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General

1. Subject has current problems with substance abuse.
2. Subject has a planned procedure that may cause non-compliance with the protocol.
3. Subject participates in another investigational drug or device clinical study that has not reached its primary endpoint.
4. Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.
5. Chronic total occlusion (CTO) of the target lesion(s) or Thrombolysis In Myocardial Infarction (TIMI) flow < 2.
6. 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.
7. Target lesion(s) within native or synthetic vessel grafts.
8. 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.
9. 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.
10. Known renal insufficiency, estimated glomerular filtration rate (eGFR) =30 mL/min, by institutional calculation.
11. Subject on dialysis, or acute kidney failure (as per physician judgment).
12. Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated or hypersensitive.
13. 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.
14. Subject has a known allergy to urethane, nylon, or silicone.
15. 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.
16. Type 2 NSTEMI
17. Presentation with ACS and ongoing chest pain and/or hemodynamic instability despite treatment of the culprit lesion
18. History of stroke/TIA within 60 days before enrollment.
19. LVEF less than or equal to 35%.
20. Subject is confined to bed.
21. History of thrombolytic therapy within two weeks of enrollment.
22. Subject is a recipient of a heart transplant.
23. Subject is unwilling/not able to return for angiographic catheterization at 6-month follow-up.
24. Women who are pregnant, breast-feeding or intend to become pregnant.
25. 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.
26. Cardiogenic shock (SBP <80mmHg requiring inotropes, IABP, or fluid support).
27. Subject has symptomatic active COVID-19 or is asymptomatic within the past 2 weeks of a positive COVID test.

Angiographic
28. Subject has a planned intervention in the left-main plus two separate major epicardial territories (left-main plus 2 vessel diseases).
29. Target vessel size <2.00 mm or >4.0 mm
30. Target lesion in the left main stem.
31. Target vessel with high thrombus burden.
32. Aorto-ostial target RCA lesion (within < 10 mm of the aorta junction)
33. 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.
34. The lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft.
35. Target lesion is located within a previous implanted stent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Victorian Heart Institute - Monash University - Clayton
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
50000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Dominican Republic
State/province [1] 0 0
Santo Domingo
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Advanced NanoTherapies
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Cardiovascular Research Foundation, New York
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05521542
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Nicholls
Address 0 0
Monash Heart
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marwan Berrada-Sounni
Address 0 0
Country 0 0
Phone 0 0
(415) 517-0867
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05521542