Biolimus A9™ (BA9™) Drug Coated Balloon (DCB) Study

Not Applicable

• Conditions: In-Stent Restenosis; Coronary Artery Disease
• Interventions: Device: Biolimus A9 Drug Coated Balloon; Device: SeQuent Please Paclitaxel Drug Coated Balloon

• Registration Number: NCT04079192
• Lead Sponsor: Biosensors Europe SA

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-stent restenosis (ISR) in a bare-metal stent (BMS) or drug-eluting stent (DES).

The study uses a prospective, multi-center, single blind, randomized controlled trial design to enroll 195 patients. The study will seek to prove that the BA9-DCB is non-inferior to the approved CE marked Sequent Please® Paclitaxel Coated Balloon with respect to % Diameter Stenosis and has similar safety characteristics.

Study Timeline

• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Study Start: 2020-08-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10
• Primary Completion: 2023-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biolimus A9™ Drug Coated Balloon	Biolimus A9 Drug Coated Balloon	Patients who meet the eligibility criteria and who are randomised to this arm, will receive treatment with the Biolimus A9™ Drug Coated Balloon
Sequent ® Please Paclitaxel coated balloon	SeQuent Please Paclitaxel Drug Coated Balloon	Patients who meet the eligibility criteria and who are randomised to this arm, will receive treatment with the Sequent ® Please Paclitaxel coated balloon

Primary Outcome Measures

Name	Time	Method
Percent Diameter Stenosis (DS)	6 months	Percent DS of the target segment assessed by quantitative coronary angiography (QCA)

Secondary Outcome Measures

Name	Time	Method
Target lesion failure	1 month, 6 months, 1 year and 2 years	Taget lesion failure defined as a composite of cardiovascular death, any target vessel myocardial infarction, coronary artery bypass graft and clinically driven target lesion revascularization
Target vessel failure	1 month, 6 months, 1 year and 2 years	Target vessel failure defined as a composite of cardiovascular death, any target vessel myocardial infarction, and clinically driven target vessel revascularization

Trial Locations

Locations (15)

Heart Center Leipzig - University of Leipzig; 🇩🇪 Leipzig, Germany

Hospital Universitario de La Princesa; 🇪🇸 Madrid, Spain

Mater Private Hospital; 🇮🇪 Dublin, Ireland

Evangelisches Krankenhaus Paul Gerhardt Stift; 🇩🇪 Wittenberg, Germany

Heart Center, Segeberger Kliniken; 🇩🇪 Bad Segeberg, Germany

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Royal Bournemouth hospital; 🇬🇧 Bournemouth, United Kingdom

University Hospital Galway; 🇮🇪 Galway, Ireland

Centro Cardiologico Monzino; 🇮🇹 Milano, Italy

Craigavon Cardiac Centre; 🇬🇧 Craigavon, United Kingdom

Dorset County Hospital; 🇬🇧 Dorchester, United Kingdom

University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom

Altnagelvin Area Hospital; 🇬🇧 Londonderry, United Kingdom

Worcestershire Royal Hospital; 🇬🇧 Worcester, United Kingdom