SELUTION SLR™ 014 In-stent Restenosis

Not Applicable

Active, not recruiting

• Conditions: Coronary Restenosis

• Registration Number: NCT04280029
• Lead Sponsor: M.A. Med Alliance S.A.

Brief Summary

Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial.

Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR™ 014 DEB or SOC to include contemporary DES (zotarolimus-eluting stents \[ZES\] and everolimus-eluting stents \[EES\] only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA.

The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR™ 014 DEB in all patients.

Detailed Description

Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial will enroll up to 418 randomized subjects (including up to 60 subjects in an angiographic and optical coherence tomography \[OCT\] sub-study) at up to 80 sites in the United States (US), Canada, Brazil, and Europe (EU). A minimum of 50% of the subjects will be enrolled in the US.

Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR™ 014 DEB or SOC to include contemporary DES (zotarolimus-eluting stents \[ZES\] and everolimus-eluting stents \[EES\] only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA.

The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR™ 014 DEB group.

A subset of up to 60 subjects will be enrolled in the angiographic and OCT sub-study and undergo planned angiographic and OCT follow-up within 30 days after completion of the 12-month primary endpoint clinical follow-up/assessment.

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Study Start: 2020-07-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-07
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 418

Inclusion Criteria

1. Subject age is ≥ 18 years or minimum legal age as required by local regulations.
2. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure.
3. Subject presents with chronic coronary syndrome (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 percutaneous coronary intervention (PCI) and planned intervention.
4. Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either Clopidogrel, Prasugrel, or Ticagrelor. Note: Subjects who require continued oral anticoagulant therapy my omit aspirin at discretion of investigator.
5. Life expectancy >1 year in opinion of investigator.
6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.

Angiographic Inclusion Criteria

1. Target lesion is within a native coronary artery or major branch.
2. Target lesion is within a previously placed BMS or DES and does not extend further than 5 mm beyond either the proximal or distal edge of the stent.
3. Up to two (2) non-target lesions in non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before treatment of the target lesion. Successful treatment is defined as no greater than 30% residual stenosis by visual estimate, no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C, and Thrombolysis in Myocardial Infarction (TIMI) grade flow in the non-target lesion > 2.
4. Target lesion is ≤ 26 mm in length.
5. Target lesion has diameter stenosis of > 50% and ≤ 99% by visual estimate.
6. Reference vessel diameter (RVD) is ≥ 2.00 mm and ≤ 4.50 mm.
7. Target lesion must be successfully pre-dilated/pre-treated. Note: Successful pre-dilation/pre-treatment is defined as dilation or pre-treatment that achieves stent expansion of approximately 80% of the distal RVD (at the discretion of the investigator) based on intravascular ultrasound (IVUS)/optical coherence tomography (OCT) and no greater than 30% residual stenosis by visual estimate and no dissection greater than NHLBI type C. TIMI grade flow in the target lesion must be > 2. Note: Atherectomy and cutting balloon are permitted for pre-treatment.

Clinical

Exclusion Criteria

1. Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.
2. ST-elevation myocardial infarction (STEMI) within 30 days.
3. Planned treatment of additional lesions in the target vessel, or more than two (2) non-target lesions within non-target vessels, during the index procedure.
4. Target lesion is located within a bifurcation with planned treatment of side branch vessel.
5. Target lesion is the 3rd or greater stent failure (i.e., more than two [2] layers of stent are present at any segment of the target lesion).
6. Target vessel had any previous vascular brachytherapy treatment or is planned to undergo brachytherapy at index procedure.
7. Previous PCI of the target vessel within 30 days.
8. Planned PCI of a non-target vessel, or a non-target lesion in the target vessel, within 30 days of randomization.
9. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate [GFR] ≤ 30 ml/min/1.73 m² within 30 days of index procedure) or has undergone renal transplantation.
10. Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output.
11. History of active peptic ulcer or gastrointestinal bleeding within prior 6 months or other inability to comply with recommended duration of DAPT.
12. Subject is pregnant, breast-feeding, or a woman of childbearing potential who is not using appropriate contraceptives to avoid becoming pregnant.
13. Documented left ventricular ejection fraction (LVEF) < 25%.
14. Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.

Angiographic Exclusion Criteria

1. Target lesion is a total occlusion or has evidence of thrombus.
2. Target lesion involves an unprotected left main.
3. Target lesion has > 30% residual stenosis by visual estimate or dissection greater than NHLBI type C after pre-dilation/pre-treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure	12 months post-index procedure	The primary safety and efficacy endpoint is TLF at 12 months post-index procedure for SELUTION SLR 014 DEB versus SOC in all patients. TLF is defined as all cardiac death, target vessel myocardial infarction (MI) or clinically driven TLF.; MI includes spontaneous (Type 1) MI using the 4th Universal Definition of Myocardial Infarction (UDMI) and peri-procedural MI using the Society for Cardiac Angiography and Intervention (SCAI) definition.

Secondary Outcome Measures

Name	Time	Method
In-segment minimal luminal diameter (MLD)	at 12 months	The powered secondary endpoint will be in-segment minimal luminal diameter (MLD) at 12 months (after documented completion of 12 months of clinical follow-up) in the angiographic follow-up subset.
Device success	at 12 months	Attainment of \< 30% residual stenosis of the target lesion using the assigned study device only.
Lesion Success	at 12 months	Attainment of \< 30% residual stenosis of target lesion using any percutaneous method.
Procedure Success	at 12 months	Attainment of \< 30% residual stenosis of the target lesion using the assigned study device only without the occurrence of in-hospital major adverse cardiac events (MACE), a composite of all-cause death, MI or clinically driven TLR.

Trial Locations

Locations (47)

Loma Linda University; 🇺🇸 Loma Linda, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

ClinRe 001-001; 🇺🇸 Thornton, Colorado, United States

MedStar Heart Institute; 🇺🇸 Washington, District of Columbia, United States

University of Florida Health; 🇺🇸 Jacksonville, Florida, United States

Baptist Cardiac & Vascular Institute; 🇺🇸 Miami, Florida, United States

Atlanta VA Medical Center; 🇺🇸 Atlanta, Georgia, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

Ascension St Vincents Heart Center; 🇺🇸 Indianapolis, Indiana, United States

Scroll for more (37 remaining)