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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05521542




Registration number
NCT05521542
Ethics application status
Date submitted
25/08/2022
Date registered
30/08/2022
Date last updated
6/02/2023

Titles & IDs
Public title
ADVANCEd NanoTherapies Dual Active Pharmacological Ingredient (Dual-API) Drug-Coated Balloon to Treat De-Novo Lesions in Patients With Symptomatic Stable Coronary Artery Disease
Scientific title
A Prospective, Single-arm, Multi-center, Feasibility First-in-human Study to Evaluate Safety and Performance of the SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter to Treat De-novo Lesions in Patients With Symptomatic Stable Coronary Artery Disease
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 coronary artery disease
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Performance Endpoint 1
Timepoint [1] 0 0
(Peri-procedural)
Primary outcome [2] 0 0
Performance Endpoint 2
Timepoint [2] 0 0
(Peri-procedural)
Primary outcome [3] 0 0
Performance Endpoint 3
Timepoint [3] 0 0
(Peri-procedural)
Primary outcome [4] 0 0
Angiographic Endpoint (by QCA):
Timepoint [4] 0 0
at 6 months after the procedure
Secondary outcome [1] 0 0
Safety Endpoint
Timepoint [1] 0 0
During procedure up to 24 hours, at 30 days, 6 months, 12 months and 24 months
Secondary outcome [2] 0 0
Angiographic and IVUS Endpoint
Timepoint [2] 0 0
at 6 months post-procedure
Secondary outcome [3] 0 0
Angiographic and IVUS Endpoint
Timepoint [3] 0 0
at 6 months post-procedure
Secondary outcome [4] 0 0
Angiographic and IVUS Endpoint
Timepoint [4] 0 0
at 6 months post-procedure
Secondary outcome [5] 0 0
Angiographic and IVUS Endpoint
Timepoint [5] 0 0
at 6 months post-procedure
Secondary outcome [6] 0 0
Angiographic and IVUS Endpoint
Timepoint [6] 0 0
at 6 months post-procedure
Secondary outcome [7] 0 0
Angiographic and IVUS Endpoint
Timepoint [7] 0 0
at 6 months post-procedure
Secondary outcome [8] 0 0
Angiographic and IVUS Endpoint
Timepoint [8] 0 0
at 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. Life expectancy > 1 year.

4. The subject is intended to undergo an angiographic procedure and coronary percutaneous
intervention. The subject is an acceptable candidate for treatment in the
Investigator's opinion and/or per hospital guidelines.

5. The subject is intended to undergo treatment with a coronary drug-coated balloon.

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.

8. The subject shall be under optimal medical therapy for ASCVD, which includes at a
minimum high-intensity statin therapy (atorvastatin 40-80 mg/d or rosuvastatin 20-40
mg/d). If statin intolerant, the patient should be treated with a PCSK9 inhibitor,
ezetimibe or bempedoic acid.

9. Subject has chronic stable angina or has had an acute coronary syndrome and the
cardiac biomarkers have returned to normal

10. Target lesion is located within a de-novo coronary artery located in a native coronary
artery with a reference vessel diameter between =2.25 mm to =4.0mm by visual estimate,
with a lesion length of equal greater 15mm to < 35mm.

11. Subject has multiple lesions that meet inclusion and exclusion criteria individually
that could be treated with a study device. To be treated with a study device, lesions
must be defined as target lesions. A maximum of three (3) lesions could be treated
during the index procedure (maximum of 2 target vessels). One (1) non-target lesion
can be staged if needed. Target lesions (up tp 2) cannot be staged. One
investigational device is to be used per target lesion.

12. Successful pre-dilation with semi and/or non-compliant balloon of the target lesion(s)
is 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 therapy
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 other serious medical illnesses (e.g., cancer, congestive heart failure)
that may reduce life expectancy to less than 12 months.

2. Subject has current problems with substance abuse.

3. Subject has a planned procedure that may cause non-compliance with the protocol or
confound data interpretation.

4. Subject participates in another investigational drug or device clinical study that has
not reached its primary endpoint.

5. Subject intends to participate in another investigational drug or device clinical
study within 12 months after the index procedure.

6. Significant target vessel tortuosity or other parameters that could prohibit access to
the target lesion.

7. Type A lesions, Chronic total occlusion (CTO) of the target lesion(s) or Thrombolysis
In Myocardial Infarction (TIMI) flow < 2.

8. Cardiogenic shock.

9. Subject requires treatment of a coronary lesion(s) involving a bifurcation.

10. Target lesion(s) within native or synthetic vessel grafts.

11. CTO of inflow vessel.

12. Subject has had any major (e.g., cardiac, peripheral, abdominal) 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.

13. Subject requires treatment of a coronary lesion distal to the target lesion(s) at the
time of the enrollment/index procedure.

14. The subject has a known coagulopathy or has a bleeding diathesis, thrombocytopenia
(with platelet counts less than 100,000/microliter) or platelets > 400,000/microliter,
or international normalized ratio >1.5. Patients on chronic oral anticoagulation
medications will be excluded of the study

15. Known renal insufficiency (e.g., serum creatinine >2.5mg/dL, or creatinine clearance
(CrCl) =30 mL/min).

16. Subject on dialysis, or acute kidney failure (as per physician judgment).

17. Subject in whom antiplatelet, anticoagulant or thrombolytic therapy is contraindicated
or hypersensitive.

18. 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.

19. Subject has a known allergy to urethane, nylon, or silicone.

20. Myocardial infarction within 60 days before enrollment.

21. History of stroke/TIA within 60 days before enrollment. LVEF <30%.

22. Subject is confined to bed.

23. Subject has a life expectancy less than 12 months.

24. History of thrombolytic therapy within two weeks of enrollment.

25. Patient is a recipient of a heart transplant.

26. Patient is unwilling/not able to return for angiographic catheterization at 6-month
follow-up.

27. Women who are pregnant, breast-feeding or intend to become pregnant.

28. Subject is planning to participate in other clinical studies before completing this
study.

29. 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.

30. Cardiogenic shock (SBP <80mmHg requiring inotropes, IABP, or fluid support).

31. Known allergies to sirolimus, paclitaxel or other components of the used medical
devices.

32. Subject with renal insufficiency (creatinine =2.0mg/dl) or failure
(dialysis-dependent).

33. Subject has suspected or proven COVID-19 positive result at present or within the past
4 weeks of informed consent form.

Angiographic

1. Subject has a planned intervention in the left-main plus two separate major epicardial
territories (left-main plus 2 vessel diseases).

2. Target vessel size <2.0 mm or >4.0 mm

3. Target lesion in the left main stem and proximal LAD.

4. The target vessel contains visible thrombus.

5. Aorto-ostial target lesion (within 3 mm of the aorta junction); including all left
main disease.

6. 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.

7. The lesion is located within an arterial or saphenous vein graft or distal to a
diseased arterial or saphenous vein graft.

8. Target lesions are located within a bifurcation of the planned treatment of
side-branch vessel.

9. Target lesion is located within a previous implanted stent.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
1/04/2025
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

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Advanced NanoTherapies
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cogent Technologies Corporation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cardiovascular Research Foundation, New York
Address [3] 0 0
Country [3] 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 =2.25 and =4.0 mm in patients with stable symptomatic
coronary artery disease.
Trial website
https://clinicaltrials.gov/ct2/show/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
mberrada@advnanot.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05521542