Clinical trial NCT04079192: Biolimus A9™ (BA9™) Drug Coated Balloon (DCB) Study
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
In-Stent Restenosis
Keywords: Drug-Coated Balloon
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who meet all the eligibility criteria will be randomized 2:1 to receive treatment with either a BA9-DCB or a Sequent Please® Paclitaxel Coated Balloon.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percent Diameter Stenosis (DS)
timeFrame: 6 months
Secondary outcomes:
measure: Target lesion failure
timeFrame: 1 month, 6 months, 1 year and 2 years
measure: Target vessel failure
timeFrame: 1 month, 6 months, 1 year and 2 years
Other outcomes:
Locations:
city: Bad Segeberg
country: Germany
facility: Heart Center, Segeberger Kliniken
city: Leipzig
country: Germany
facility: Heart Center Leipzig - University of Leipzig
city: Wittenberg
country: Germany
facility: Evangelisches Krankenhaus Paul Gerhardt Stift
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Craigavon
country: United Kingdom
facility: Craigavon Cardiac Centre
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital
city: Worcester
country: United Kingdom
facility: Worcestershire Royal Hospital
Study officials:
affiliation: Mater Private Hospital
name: Robert A Byrne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: