Coronary Artery Disease
Conditions
Keywords
Drug Coated Ballon, DCB, Coronary Artery Disease
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.
Detailed description
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™.
Interventions
DEVICESirPlux 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
Sponsors
Monash University
Cardiovascular Research Foundation, New York
Advanced NanoTherapies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-center, single-arm, feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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 Inclusion Criteria: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | (Peri-procedural) | Defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device without burst below rated burst pressure |
| Technical Success | (Peri-procedural) | 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 |
| Procedural Success | (Peri-procedural) | 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) |
| In-segment Late Lumen Loss (LLL) by QCA | 6 months post-procedure | difference in minimum lumen diameter, as determined by QCA, from baseline (immediately post-DCB) to 6 months post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 30 days, 6 months, 12 months and 24 months post-procedure | • 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 |
| All revascularizations (TLR, TVR and non-TVR) | 30 days, 6 months, 12 months and 24 months post-procedure | • All revascularizations (TLR, TVR and non-TVR) as a composite of TLR, TVR, and non-TVR |
| In-segment (in balloon) percent diameter stenosis (%DS) by QCA | 6 months post-procedure | In-segment (in balloon) percent diameter stenosis (% diameter stenosis; %DS). |
| In-segment binary angiographic restenosis (BAR) rate by QCA | 6 months post-procedure | In-segment binary angiographic restenosis (BAR) is defined as ≥50% diameter stenosis. |
| All-cause death | 24 hours post-discharge | 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) |
| In-segment Change in IVUS minimum lumen area (MLA, mm2) by IVUS | at 6 months post-procedure | In-segment Change in IVUS MLA (mm2) from baseline to 6 months post-procedure |
| In-segment change in mean lumen area (mm2) by IVUS | 6 months post-procedure | In-segment change in mean lumen area (mm2) from baseline to 6 months post-procedure |
| In-segment change in percentage atheroma volume by IVUS | 6 months post-procedure | In-segment change in percentage atheroma volume from baseline to 6 months post-procedure |
| In-segment serial IVUS remodeling | 6 months post-procedure | In-segment Serial IVUS remodeling (change in vessel area or volume) from baseline to 6 months post-procedure |
| In-segment Minimum Luminal/Lumen Diameter (MLD) by QCA | 6 months post-procedure | In-segment Minimum Luminal/Lumen Diameter (MLD) change from baseline to 6 months post-procedure |
| Target Vessel Myocardial Infarction (TVMI) | 30 days, 6 months, 12 months and 24 months post-procedure | • Target Vessel Myocardial Infarction (TVMI) |
| Major Adverse Cardiac Event (MACE) | 30 days, 6 months, 12 months and 24 months post-procedure | • 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 |
| Target Vessel Failure (TVF) | 30 days, 6 months, 12 months and 24 months post-procedure | • 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 |
Countries
Australia, Dominican Republic, New Zealand
Outcome results
None listed