Status:
UNKNOWN
Biolimus A9™ (BA9™) Drug Coated Balloon (DCB) Study
Lead Sponsor:
Biosensors Europe SA
Conditions:
Coronary Artery Disease
In-Stent Restenosis
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The study is a Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis. It is a First-in-Man Trial.
Detailed Description
This clinical trial will serve as a first-in-human (FIH) experience for the BA9™ DCB in a population of patients with coronary artery disease who have an indication for interventional treatment of in-...
Eligibility Criteria
Inclusion
- Patients presenting with in-stent restenosis (ISR) and clinical symptoms of ischemia and/or (i) evidence of ischemia on non-invasive testing or (ii) hemodynamically relevant lesion defined by FFR ≤ 0.80 or iFR ≤ 0.89 or \> 90% stenosis.
- Patient presenting with a lesion that can be fully covered with one DCB length. - Patients can have up to two index lesions with ISR, which can both be treated and evaluated.
- Patient has provided written informed consent
- Age ≥ 18 years.
- Patient is willing and able to comply with the study procedures and follow-up.
Exclusion
- Patient presents with a ST-elevation myocardial infarction (STEMI) or had an acute MI within 48 hours prior to presentation (according to the universal definition of myocardial infarction).
- Patient with acute cardiac decompensation or acute cardiogenic shock
- Documented left ventricular ejection fraction (LVEF) ≤ 30%
- Patient with impaired renal function (glomerular filtration rate \< 80 mL/min/1.73 m2).
- More than 2 epicardial vessels requiring revascularization
- Significant left main stenosis (by visual estimation) or an ISR located in the left main (LM).
- Patient has an ISR lesion that cannot be covered with one DCB length.
- Patient has an ISR in the target segment in a stent of a smaller diameter than 2.5mm.
- Severe calcification that might prevent a sufficient expansion of the DCB, if not pre-treated with rotablation or a shockwave application device.
- Known hypersensitivity or contraindication to biolimus, paclitaxcel, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.
- Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
- Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.
- Anticipated difficulties to complete the angiographic follow-up study.
- Patient with a life expectancy of less than 12 months.
- Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT04079192
Start Date
August 7 2020
End Date
April 1 2024
Last Update
August 10 2022
Active Locations (15)
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1
Heart Center, Segeberger Kliniken
Bad Segeberg, Germany
2
Heart Center Leipzig - University of Leipzig
Leipzig, Germany
3
Evangelisches Krankenhaus Paul Gerhardt Stift
Wittenberg, Germany
4
Mater Private Hospital
Dublin, Ireland