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

NCT ID: NCT04079192

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-07
• Study Completion Date: 2024-04-30

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.

Conditions

Coronary Artery Disease; In-Stent Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Biolimus A9 Drug Coated Balloon

Intervention Type: DEVICE

A non-surgical procedure that uses a catheter to place a semi-compliant angioplasty drug coated balloon to open up coronary arteries that have been narrowed by atherosclerosis. The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.

Sequent ® Please Paclitaxel 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

Group Type: ACTIVE_COMPARATOR

SeQuent Please Paclitaxel Drug Coated Balloon

Intervention Type: DEVICE

A non-surgical procedure that uses a catheter to place a semi-compliant angioplasty drug coated balloon to open up coronary arteries that have been narrowed by atherosclerosis. The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.

Interventions

Biolimus A9 Drug Coated Balloon

A non-surgical procedure that uses a catheter to place a semi-compliant angioplasty drug coated balloon to open up coronary arteries that have been narrowed by atherosclerosis. The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.

Intervention Type: DEVICE

SeQuent Please Paclitaxel Drug Coated Balloon

A non-surgical procedure that uses a catheter to place a semi-compliant angioplasty drug coated balloon to open up coronary arteries that have been narrowed by atherosclerosis. The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosensors Europe SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert A Byrne, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mater Private Hospital

Locations

Heart Center, Segeberger Kliniken

Bad Segeberg, , Germany

Heart Center Leipzig - University of Leipzig

Leipzig, , Germany

Evangelisches Krankenhaus Paul Gerhardt Stift

Wittenberg, , Germany

Mater Private Hospital

Dublin, , Ireland

University Hospital Galway

Galway, , Ireland

Centro Cardiologico Monzino

Milan, , Italy

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Universitario de La Princesa

Madrid, , Spain

Royal Bournemouth hospital

Bournemouth, , United Kingdom

University Hospital of Wales

Cardiff, , United Kingdom

Craigavon Cardiac Centre

Craigavon, , United Kingdom

Dorset County Hospital

Dorchester, , United Kingdom

Altnagelvin Area Hospital

Londonderry, , United Kingdom

Worcestershire Royal Hospital

Worcester, , United Kingdom

Countries

Germany; Ireland; Italy; Spain; United Kingdom

References

Byrne RA, Hahn JY, O'Kane P, Sabate M, Toelg R, Copt S, Fitzgerald S, Morice MC, Trevelyan J, Mylotte D, Ortiz AF, Rai H, Durand R, Wohrle J, Kleber FX, Stefanini G, Alfonso F. Randomized Trial of Biolimus DCB for In-Stent Restenosis: The Primary Results of the REFORM Study. JACC Cardiovasc Interv. 2025 Mar 10;18(5):654-662. doi: 10.1016/j.jcin.2024.11.026. Epub 2025 Feb 5.

Reference Type: DERIVED

PMID: 39918494 (View on PubMed)

Traynor BP, Fitzgerald S, Alfonso F, O'Kane P, Sabate M, Tolg R, Trevelyan J, Hahn JY, Mylotte D, Wohrle J, Rai H, Cortese B, Morice MC, Schuette D, Copt S, Oldroyd KG, Byrne RA; REFORM investigators. Design and rationale of a prospective, randomized, non-inferiority trial to determine the safety and efficacy of the Biolimus A9 drug coated balloon for the treatment of in-stent restenosis: First-in-man trial (REFORM). Cardiovasc Revasc Med. 2023 Nov;56:75-81. doi: 10.1016/j.carrev.2023.06.004. Epub 2023 Jun 6.

Reference Type: DERIVED

PMID: 37328392 (View on PubMed)

Other Identifiers

19-EU-01

Identifier Type: -

Identifier Source: org_study_id