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Advanced NanoTherapies Dual-API DCB to Treat De-Novo Lesions in Patients With Symptomatic Coronary Artery Disease
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.
Study details:
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™.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-01-30
Primary completion: 2024-12-31
Study completion finish: 2027-03-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT05521542
Intervention or treatment
DEVICE: SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter
Conditions
- • Coronary Artery Disease
Find a site
Closest Location:
The Prince Charles Hospital
Research sites nearby
Select from list below to view details:
The Prince Charles Hospital
Chermside, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Victorian Heart Institute - Monash University
Clayton, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: SirPlux™ Duo Dual-API Coated PTCA Balloon Catheter
| DEVICE: SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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) | 24 hours post-discharge |
Target Vessel Myocardial Infarction (TVMI) | • Target Vessel Myocardial Infarction (TVMI) | 30 days, 6 months, 12 months and 24 months post-procedure |
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 | 30 days, 6 months, 12 months and 24 months post-procedure |
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 | 30 days, 6 months, 12 months and 24 months post-procedure |
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 | 30 days, 6 months, 12 months and 24 months post-procedure |
All revascularizations (TLR, TVR and non-TVR) | • All revascularizations (TLR, TVR and non-TVR) as a composite of TLR, TVR, and non-TVR | 30 days, 6 months, 12 months and 24 months post-procedure |
In-segment (in balloon) percent diameter stenosis (%DS) by QCA | In-segment (in balloon) percent diameter stenosis (% diameter stenosis; %DS). | 6 months post-procedure |
In-segment binary angiographic restenosis (BAR) rate by QCA | In-segment binary angiographic restenosis (BAR) is defined as ≥50% diameter stenosis. | 6 months post-procedure |
In-segment Minimum Luminal/Lumen Diameter (MLD) by QCA | In-segment Minimum Luminal/Lumen Diameter (MLD) change from baseline to 6 months post-procedure | 6 months post-procedure |
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 | at 6 months post-procedure |
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 | 6 months post-procedure |
In-segment change in percentage atheroma volume by IVUS | In-segment change in percentage atheroma volume from baseline to 6 months post-procedure | 6 months post-procedure |
In-segment serial IVUS remodeling | In-segment Serial IVUS remodeling (change in vessel area or volume) from baseline to 6 months post-procedure | 6 months post-procedure |
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