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

Coronary Artery Disease Clinical Trial

— REFORM  

Official title:

A Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9TM Drug Coated Balloon for the Treatment of In-Stent Restenosis: First-in-Man Trial (REFORM)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04079192
• Other study ID #: 19-EU-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: April 2024

Study information

• Verified date: August 2022
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 201
• Est. completion date: April 2024
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• In-Stent Restenosis

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Heart Center, Segeberger Kliniken	Bad Segeberg
Germany	Heart Center Leipzig - University of Leipzig	Leipzig
Germany	Evangelisches Krankenhaus Paul Gerhardt Stift	Wittenberg
Ireland	Mater Private Hospital	Dublin
Ireland	University Hospital Galway	Galway
Italy	Centro Cardiologico Monzino	Milano
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Biosensors Europe SA

Countries where clinical trial is conducted

Germany,  Ireland,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Diameter Stenosis (DS)	Percent DS of the target segment assessed by quantitative coronary angiography (QCA)	6 months
Secondary	Target lesion failure	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	1 month, 6 months, 1 year and 2 years
Secondary	Target vessel failure	Target vessel failure defined as a composite of cardiovascular death, any target vessel myocardial infarction, and clinically driven target vessel revascularization	1 month, 6 months, 1 year and 2 years