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

  • Subject age is ≥ 18 years or minimum legal age as required by local regulations.
  • Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure.
  • 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.
  • 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.
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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?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Dohad, Suhail

Age Group

Adult

Phase

N/A

IRB Number

SEL-003-2019

ClinicalTrials.gov ID

NCT04280029

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org