search
Back to results

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

Primary Purpose

Coronary Artery Disease, In-Stent Restenosis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Biolimus A9 Drug Coated Balloon
SeQuent Please Paclitaxel Drug Coated Balloon
Sponsored by
Biosensors Europe SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug-Coated Balloon

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Heart Center, Segeberger Kliniken
  • Heart Center Leipzig - University of Leipzig
  • Evangelisches Krankenhaus Paul Gerhardt Stift
  • Mater Private Hospital
  • University Hospital Galway
  • Centro Cardiologico Monzino
  • Hospital Clinic de Barcelona
  • Hospital Clinico San Carlos
  • Hospital Universitario de La Princesa
  • Royal Bournemouth hospital
  • University Hospital of Wales
  • Craigavon Cardiac Centre
  • Dorset County Hospital
  • Altnagelvin Area Hospital
  • Worcestershire Royal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biolimus A9™ Drug Coated Balloon

Sequent ® Please Paclitaxel coated balloon

Arm Description

Patients who meet the eligibility criteria and who are randomised to this arm, will receive treatment with the Biolimus A9™ 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

Outcomes

Primary Outcome Measures

Percent Diameter Stenosis (DS)
Percent DS of the target segment assessed by quantitative coronary angiography (QCA)

Secondary Outcome Measures

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
Target vessel failure
Target vessel failure defined as a composite of cardiovascular death, any target vessel myocardial infarction, and clinically driven target vessel revascularization

Full Information

First Posted
August 27, 2019
Last Updated
August 9, 2022
Sponsor
Biosensors Europe SA
search

1. Study Identification

Unique Protocol Identification Number
NCT04079192
Brief Title
Biolimus A9™ (BA9™) Drug Coated Balloon (DCB) Study
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosensors Europe SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, In-Stent Restenosis
Keywords
Drug-Coated Balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
The subject will be blinded to the study treatment.
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biolimus A9™ Drug Coated Balloon
Arm Type
Experimental
Arm Description
Patients who meet the eligibility criteria and who are randomised to this arm, will receive treatment with the Biolimus A9™ Drug Coated Balloon
Arm Title
Sequent ® Please Paclitaxel coated balloon
Arm Type
Active Comparator
Arm Description
Patients who meet the eligibility criteria and who are randomised to this arm, will receive treatment with the Sequent ® Please Paclitaxel coated balloon
Intervention Type
Device
Intervention Name(s)
Biolimus A9 Drug Coated Balloon
Intervention Description
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
Intervention Name(s)
SeQuent Please Paclitaxel Drug Coated Balloon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Diameter Stenosis (DS)
Description
Percent DS of the target segment assessed by quantitative coronary angiography (QCA)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Target lesion failure
Description
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
Time Frame
1 month, 6 months, 1 year and 2 years
Title
Target vessel failure
Description
Target vessel failure defined as a composite of cardiovascular death, any target vessel myocardial infarction, and clinically driven target vessel revascularization
Time Frame
1 month, 6 months, 1 year and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Byrne, MD, PhD
Organizational Affiliation
Mater Private Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center, Segeberger Kliniken
City
Bad Segeberg
Country
Germany
Facility Name
Heart Center Leipzig - University of Leipzig
City
Leipzig
Country
Germany
Facility Name
Evangelisches Krankenhaus Paul Gerhardt Stift
City
Wittenberg
Country
Germany
Facility Name
Mater Private Hospital
City
Dublin
Country
Ireland
Facility Name
University Hospital Galway
City
Galway
Country
Ireland
Facility Name
Centro Cardiologico Monzino
City
Milano
Country
Italy
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
Country
Spain
Facility Name
Royal Bournemouth hospital
City
Bournemouth
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
Craigavon Cardiac Centre
City
Craigavon
Country
United Kingdom
Facility Name
Dorset County Hospital
City
Dorchester
Country
United Kingdom
Facility Name
Altnagelvin Area Hospital
City
Londonderry
Country
United Kingdom
Facility Name
Worcestershire Royal Hospital
City
Worcester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs