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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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™.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, multi-center, single-arm, feasibility study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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™.

Group Type EXPERIMENTAL

SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter

Intervention Type DEVICE

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

Interventions

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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 Type DEVICE

Eligibility Criteria

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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.

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.
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.

Exclusion Criteria

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.

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.
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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No