- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04079192
Biolimus A9™ (BA9™) Drug Coated Balloon (DCB) Study (REFORM)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bad Segeberg, Germany
- Heart Center, Segeberger Kliniken
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Leipzig, Germany
- Heart Center Leipzig - University of Leipzig
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Wittenberg, Germany
- Evangelisches Krankenhaus Paul Gerhardt Stift
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Dublin, Ireland
- Mater Private Hospital
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Galway, Ireland
- University Hospital Galway
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Milano, Italy
- Centro Cardiologico Monzino
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Barcelona, Spain
- Hospital Clinic de Barcelona
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Madrid, Spain
- Hospital Clinico San Carlos
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Madrid, Spain
- Hospital Universitario de La Princesa
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Bournemouth, United Kingdom
- Royal Bournemouth Hospital
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Cardiff, United Kingdom
- University Hospital of Wales
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Craigavon, United Kingdom
- Craigavon Cardiac Centre
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Dorchester, United Kingdom
- Dorset County Hospital
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Londonderry, United Kingdom
- Altnagelvin Area Hospital
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Worcester, United Kingdom
- Worcestershire Royal Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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
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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.
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Active Comparator: 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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Diameter Stenosis (DS)
Time Frame: 6 months
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Percent DS of the target segment assessed by quantitative coronary angiography (QCA)
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Target lesion failure
Time Frame: 1 month, 6 months, 1 year and 2 years
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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
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1 month, 6 months, 1 year and 2 years
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Target vessel failure
Time Frame: 1 month, 6 months, 1 year and 2 years
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Target vessel failure defined as a composite of cardiovascular death, any target vessel myocardial infarction, and clinically driven target vessel revascularization
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1 month, 6 months, 1 year and 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert A Byrne, MD, PhD, Mater Private Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Umirolimus
Other Study ID Numbers
- 19-EU-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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