SELUTION 4 De Novo Small Vessel IDE Trial

ID#: NCT05946629

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: October 20, 2023

End Date: August 01, 2029

Contact Information:
Rebecca Apruzzese
Susanne Meis
Summary: Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA. The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.

Inclusion Criteria:

- Clinical Inclusion Criteria Subjects must meet all of the following clinical criteria to participate in the trial:

1. Subject is ≥ 18 years (or the minimum legal age as required by local regulations).

2. Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.

3. Subject presents with chronic coronary syndromes [CCS] (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for PCI and planned intervention.

4. Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For subjects requiring oral anticoagulation, aspirin may be omitted based on investigator discretion).

5. Subject has life expectancy > 1 year in the opinion of the investigator.

6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations. Imaging Inclusion Criteria Subject's target lesion(s) must meet all of the following angiographic criteria for the subject to participate in the trial:

1. A single, target lesions that meet criteria can be treated in a single vessel. No non-target lesions can be treated within the target vessel in the index procedure. Non-target lesions within the target vessel can be staged for treatment > 30 days from the index procedure.

2. Up to two (2) non-target lesions in up to two (2) non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before randomization and treatment of the target lesion.

3. Target lesion is ≤ 36 mm in length.

4. Target lesion has diameter stenosis > 50% and ≤ 99% with distal flow at least thrombolysis in myocardial infarction (TIMI) 2.

5. Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm [by visual assessment].

6. Target lesion is within a native coronary artery or major branch.

7. A target lesion within or near a bifurcation is allowed only if a single vessel (either main vessel or side branch) is to be treated.

8. The identified target lesion has high probability (> 70%) for successful treatment with approved pre-treatment techniques and DEB alone.

Exclusion Criteria:

- Clinical Exclusion Criteria Subjects who meet any of the following clinical criteria will be excluded from the trial:

1. Subject with known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.

2. Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.

3. Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.

4. Subject with planned major surgery within 30 days following the index procedure.

5. Subject with planned treatment of lesion involving aorto-ostial location.

6. Subject with planned PCI of a non-target vessel within 30 days following the index procedure.

7. Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure.

8. Subject with history of active peptic ulcer or gastrointestinal bleeding within 6 months of the index procedure or other inability to comply with the recommended duration of dual antiplatelet therapy (DAPT).

9. Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure.

10. Subjects with current documented left ventricular ejection fraction (LVEF) < 30%.

11. Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated.

12. Subjects is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.

13. Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure.

- Angiographic Exclusion Criteria Subject whose target lesion(s) meet any of the following angiographic criteria will be excluded from the trial:

1. Target lesion is totally occluded or has evidence of thrombus.

2. Target lesion is located in the left main or any arterial or venous graft.

3. Target lesion is in a side branch that is "jailed" by a main vessel stent.

4. In stent restenosis