SELUTION SLR 014 Drug Eluting Balloon in the Treatment of In-Stent Restenosis

What is the Purpose of this Study?

The purpose of this study is to demonstrate whether an investigational device called the SELUTION SLR drug eluting balloon is well tolerated and whether it works as effectively as other currently available treatments for patients with in-stent restenosis (narrowing) of the heart arteries. The study will compare treatment with SELUTION SLR drug eluting balloon to standard treatment of either drug coated-stent (using the drugs zotarolimus or everolimus) or a plain balloon with no drug. The study focuses on patients who previously had a stent placed in one (or more) of their coronary arteries and who have now developed a narrowing inside the stent. Procedures include coronary angiogram (invasive x-ray of the heart), angina (chest pain) assessments, and annual follow-ups. The SELUTION The SLR balloon is used to open up narrowings that occur in blood vessels inside coronary artery stents. Its unique feature is that the surface of the balloon is coated with a drug called sirolimus that is released over time. Sirolimus is used to prevent thickening of the blood vessel wall, in addition to preventing the blood vessel from narrowing again after it has been opened by the balloon.

Eligibility

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.

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.
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.
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.
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.

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

SELUTION SLR? 014 ISR: A Prospective Randomized Single Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR? 014 Drug Eluting Balloon in the Treatment of Subjects with In-stent Restenosis

Study Details

Disease Type/Condition

Other

Principal Investigator

Dohad, Suhail

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002763

ClinicalTrials.gov ID

NCT04280029

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org